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Saudi Journal of Kidney Diseases and Transplantation
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SPECIAL ARTICLE Table of Contents   
Year : 2001  |  Volume : 12  |  Issue : 2  |  Page : 191-212
Recommended Standards for Peritoneal Dialysis

Consultant Physician and Nephrologist, Oldchurch Hospital, Romford, Essex, United Kingdom

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How to cite this article:
Fahal IH. Recommended Standards for Peritoneal Dialysis. Saudi J Kidney Dis Transpl 2001;12:191-212

How to cite this URL:
Fahal IH. Recommended Standards for Peritoneal Dialysis. Saudi J Kidney Dis Transpl [serial online] 2001 [cited 2022 Jan 20];12:191-212. Available from: https://www.sjkdt.org/text.asp?2001/12/2/191/33812

In a series of articles, I will summarize The UK Renal Association document "Treatment of adult patients with renal failure - Recommended standards and audit measures". The purpose of the document is to provide a framework of quality standards and guidelines on patient specific indicators that may be relevant in determining the well-being of, and outcomes in, patients with renal disease, in particular those with end stage renal failure.

In providing a summary of the document, I hope to encourage local nephrologists to prepare a local standards document based on the local variance of the disease and population characteristics, aiming to protect patients from the effects of substandard treatment and to improve the general quality of their care.

Strength of supporting evidence

The strength of the evidence that adherence to a minimum standard will benefit patients is variable and in many areas low (B to C in the grading of the US Department of Health and Human Services (1992)*). The few controlled trials that have been done are identified as such in the reference list (CT); reviews (identified by Review), often not strictly peer reviewed, are marked also to indicate the strength of the evidence. In some cases no firm evidence is available, and interpretation must be circumspect.

The recommendations in this document are therefore titled:

'Recommended standard' if the available evidence is strong, 'Recommendation' if it is weaker or speculative.

Some recommendations address organi­sational or ethical issues and have not been allocated evidence related grades. * Strength of recommendation:

A = Evidence from at least one properly performed randomized controlled trial (quality of evidence Ib) or meta-analysis of several controlled trials (quality of evidence Ia).

B = Well conducted clinical studies, but no randomized clinical trials; evidence may be extensive but essentially descriptive (evidence levels IIa, IIb, III).

C = Evidence (level IV) obtained from expert committee reports or opinions, and/or clinical experience of respected authorities. This grading indicates an absence of directly applicable studies of good quality.

   Recommended Standards for Peritoneal Dialysis Top


A unit offering peritoneal dialysis (PD) should provide not only continuous ambu­latory peritoneal dialysis (CAPD) but also automated peritoneal dialysis (APD), which includes continuous cycling peritoneal dialysis (CCPD), intermittent peritoneal dialysis (IPD) and nightly intermittent peritoneal dialysis (NIPD). It should have access to adequate back-up hemodialysis (HD) facilities and renal transplantation.

The unit should be aware of the limitations of CAPD and related techniques. In particular, in patients with large muscle mass and no or little residual function it may provide inadequate dialysis however the treatment regime is adjusted. It is, in contrast, particularly suitable for smaller patients taken on early with considerable residual renal function.

Biomedical equipment

All electromechanical equipment used to undertake PD should comply with national and international standards for electro­mechanical safety. There is a need to establish an official body to set safety standards and oversee and regulate PD equipment's nationally and regionally, as is the case in Europe. PD equipment should be purchased from manufacturers registered with this official body.

Solutions for PD

Fluids for PD need to satisfy current European quality standards enshrined in the European Goods Manufacturing Practice.

In selected patients, specialized solutions such as amino acid containing solutions or glucose polymers are preferable to standard solutions. [1] Other solutions with variations in the concentration of calcium, magnesium, osmotic agents and buffers also will be needed. Such solutions are likely to be more expensive, so their selective use should be reflected in negotiations with purchasers.

CAPD systems

Disconnect, 'flush before fill' systems are superior to earlier systems. In controlled trials, their use results in a significantly lower incidence of peritonitis and a better quality of life. [2],[3] Such systems should be standard for all patients, unless they are incapable of managing this slightly more difficult technique. Extra costs should be partly offset by lower morbidity, hospital admission and peritoneal failure rates, as suggested by the study of Harris et al. [4]

Recommended Standard (A)

The use of disconnect systems should be standard unless contraindicated.

Automated peritoneal dialysis

The use of cycling machines at home may be necessary for clinical reasons, for example, high transporter status of the peritoneum (10-15% of the dialysis population), those with impaired filtration, or for psychosocial reasons; these three groups together form 20-25% of the total CAPD population. Therefore, APD should be available for selected patients. Monitoring of the dose of dialysis delivered is especially important in APD. Automated systems are more expensive than standard disconnect manual systems; their extra costs will need to be reflected in contracts negotiated with purchasers, but it should be noted that usually APD will be cheaper for these patients than the alternative, i.e., transfer to in-center HD.

Recommendation (C)

Automated peritoneal dialysis should be available as clinically indicated and not constrained by financial considerations.

Clinical standards

Only issues that are specific to PD are discussed here. Issues common to HD and PD such as:

~ Correction of anemia

~ Control of blood pressure

~ Prevention of transmissible infections to patients and staff will be discussed under hemodialysis.

Nutritional status

Protein malnutrition with low serum albumin is a powerful predictor of mortality in dialysis patients using CAPD as well as HD. [5],[6] Additional losses not faced by HD patients are present: amino acids to the equivalent of 0.2 g/kg/24 h are lost in the dialysate together with 0.12 g protein/kg/24 h.

Although it is likely that a high prevalence of hypoalbuminemia reflects under-dialysis, a direct causal relationship between Kt/V and serum albumin has not been proven. There is no one parameter that ideally measures nutritional status in a simple non­invasive manner, but skin fold thickness and mid-arm circumference, used alone or as part of a composite nutritional index, have been shown to be reasonable indicators in CAPD patients. [7]

Malnutrition can be recognised by a reduced serum albumin, actual body weight <90% of ideal body weight for height, and estimated protein intake <0.8 g/kg ideal body weight for height/24 h. [8] Every effort to promote nutrition by enteral or, if necessary, by parenteral routes is strongly recommended in such patients. Vegetarians, in particular, may show serum albumin concentrations lower than the recommended concentration.

Recommendation (B)

A protein intake greater than 1.2 g/kg ideal body weight for height/24 h together with an oral calorie intake, including glucose absorption from the dialysate, of >35 kcal/kg ideal body weight for height/24 h should be attained by all patients.

The serum albumin of at least 70% of patients should be within the local normal range.

Biochemical profiles

Electrolyte homeostasis in dialysis patients is to some extent under the control of dialysis staff and is an indicator of the quality of care given; however, dietary indiscretions and non-compliance also undoubtedly influence it. The ideal target concentration of calcium has not been established firmly. Since it is desirable to avoid the use of aluminium containing phosphate-binding agents, low calcium dialysate is becoming more popular.

Recommended standard (B)

Potassium 3.5-5.5 mmol/l*

Phosphate 1.1-1.6 mmol/l

Calcium within normal limits for local laboratory, corrected for serum albumin concentration, or normal ionized calcium where available.

*It should be noted that in subjects on dialysis approximately 50% of potassium is dialyzed, but the other 50% is excreted via the gut. A number of medicines, including angiotensin-converting enzyme inhibitors, non-steroidal anti-inflammatory agents and beta-blockers, interfere with this secretion and cause hyperkalemia even with an adequate restriction of oral potassium.


Currently the estimation of immunoreactive parathormone (iPTH) by an intact hormone assay is the best non-invasive method for assessing parathyroid activity and renal bone disease. Values in excess of three times the upper limit of the normal range (10-70 pg/ml, ie >210 pg/ml) (1.1-7.4, ie >22 ng/ml) usually indicate parathyroid overactivity, whilst values of <50 pg/ml (5.3 ng/ml) suggest the presence of adynamic bone. The latter finding is commoner in CAPD patients than in those receiving HD, [9] but it is symptom less and its long-term natural history is unknown; however, it is associated clinically with metastatic calcification, and biochemically with a relative inability to dispose of a calcium load. [10]

As in patients receiving HD, there is controversy about how strictly the serum parathormone concentration should be controlled, [11],[12] in view of the potential dangers of adynamic bone; the current consensus is that 'mild activity' is desirable.

Recommendation (B)

iPTH (intact hormone assay) should be maintained at between 2 and 3 times the upper limit of the local normal range (130­210 pg/mI).

Acidosis and alkalosis

Correction of acidosis is readily achieved in CAPD by the use of higher lactate or bicarbonate based PD fluids and of oral calcium carbonate as phosphate binder. A mild alkalosis may be seen in patients using low calcium dialysis fluid, the use of which avoids the need for aluminium containing phosphate-binding agents.

Recommended Standard (B)

The serum bicarbonate level should not fall below the local normal range, or rise more than 3 mmol/l above it.

Peritoneal equilibration tests

A peritoneal equilibration test (PET) [13] assesses the peritoneal membrane transporter status. It may be helpful in prescribing the appropriate PD regimen but is of limited value in prescribing the dose, and it takes 4­6 weeks after starting dialysis to stabilize. [14] Its main utility is in assessing peritoneal membrane function, in particular loss of ultrafiltration. [15]

Recommended Standards (B)

PET tests should be performed after 4-8 weeks on dialysis, when clinically indicated, e.g. when biochemical indices raise suspicion of changes in peritoneal transport characteristics, and annually as a routine.

Adequacy of CAPD

The concept of adequacy is very important. It has been shown in prospective studies to be a predictor of outcome in new patients starting CAPD [16] and in patients already on CAPD treatment. [17],[18] As with patients on HD, adequacy is a global concept, involving various levels of measurement, which include clinical assessment of well-being and physical measurements, measures of small molecule solute clearance and fluid removal, and the impact of the treatment on the patient's life. It is important that clinical aspects be taken into consideration in arriving at targets of small molecule solute clearance, which in general are the basis for measuring dialysis dose.

Prescribing CAPD

Prescribing the dialysis dose and measuring the adequacy of dialysis are best done during the initiation phase immediately after starting CAPD, and in a subsequent phase when the dose is assessed and monitored. Since the PET test takes 4-6 weeks to stabilize, values obtained earlier than this may not be representative of membrane transport characteristics. Hence, the initial CAPD regimen should be prescribed assuming normal transport characteristics and in the light of measured residual renal function and maximally tolerated peritoneal dwell volume.

After 4-6 weeks, a PET test should be done to assess peritoneal transport characteristics. Patients with high transport characteristics (who form a higher proportion of patients in the UK than in studies from the United States) may not be suitable for standard CAPD exchanges, and will often require short-dwell APD. Those with low transporter status may be unsuitable for PD altogether, unless they have good residual function. Subsequently, the dialysis dose can be monitored on an annual basis or as indicated clinically.

Quantity of dialysis delivered

There is even less consensus than for HD about both the best methods to measure the dose of PD [19] and the link between dialysis dose and outcome. [20],[21],[16] In general, non­-prospective data show that less may be worse, but as yet no data show that increasing small molecule solute clearance in PD patients beyond the standard four exchanges of 2 litres improves survival. [22]

As for HD, the most favored methods to assess dialysis dose in CAPD at the moment, use small molecule solute clearances as a surrogate for the as yet unknown toxic metabolites accumulating in uremia; this may be even more inappropriate for CAPD than for HD because of the greater clearance for larger solutes that CAPD provides.

Kt/V (urea) and weekly creatinine clearance

Nevertheless, the weekly Kt/V for urea and the weekly creatinine clearance are both frequently used at the moment. Each is the sum of the clearance achieved by the dialysis and that due to the residual renal function. It should be noted that the expression of creatinine clearance (Ccr) in litres/week conceals just how marginal the achieved clearances are: 60 1/week represents less than 5.9 ml/min of creatinine clearance, 70 1/week <6.9 ml/min, and 80 1/week <7.9 ml/min. Furthermore, even on CAPD the glomerular filtration rate (GFR) falls from a mean of 4 ml/min at the start of dialysis to about 1-1.5 ml/min by 2 years, [16] even though this rate of decline is much slower on CAPD than on HD. [23] No data are yet available for decline in residual function on APD. Thus, to achieve the same total small molecule solute clearance, the dialysis clearance will need to be increased, especially in those on dialysis for longer than 2 years or already anuric. Also, the two measure­ments of small molecule solute clearance differ in their susceptibility to manipulation; in practice, creatinine clearance is much more difficult to increase than Kt/V for urea.

A weekly Kt/V <1.65 was reported to be associated with poor outcome, [24],[25] and a weekly Kt/V >1.9 (dialysis + residual renal function) or total weekly creatinine clearance of >60 l/week/1.73 m 2 of body surface area has been advocated for standard CAPD, [16] even higher clearances being suggested in recent publications [26],[27],[28],[16] reported a steady decrease in survival with lower initial creatinine clearances (including residual renal function), from 100 l/week (9.9 ml/min) to 30 l/week, but no clearances subsequent to those measured at the beginning of dialysis were reported in these patients.

It must be emphasized also that all these studies were based largely on theoretical predictions, even though these have been validated to some extent against actual experience, [29] and that there is no final proof that achieving these targets will result in improved outcome. [22] In the CANUSA (Canada and US collaboration) study, [16] three-quarters of the deaths during treatment within 2 years of starting CAPD were from cardiovascular causes, some in well dialyzed patients.

Other modes of peritoneal dialysis

APD comprises a number of regimes involving varying amounts of fluid and dwell times (CCPD, NIPD, NIPD with 'wet' days, and tidal PD). There are few data on either solute clearances or impact on outcome of such regimes. If the hypothesis that peak concentrations of solutes are the most important proves to be correct, intermittent therapies will need higher targets for solute clearance. [19]

Thus, the recommendations given imme­diately below can be regarded merely as approximate targets for which to aim, which can be refined in the light of more data. Again, we emphasize that the general state of the patient must be taken into account when prescribing quantity of CAPD; a well nourished patient with good bio­chemistry and hemoglobin but apparently unsatisfactory clearance is more reassuring than an ill patient with poor metabolic control but apparently good clearance. Finally, even though V is a function of body size, weekly Kt/V or total creatinine clearance needs to be prescribed on an individual basis, [30] especially with regard to the maximally tolerated volume of dialysate.


A total weekly creatinine clearance (dialysis + residual renal function) of 50 l/week/1.73 m 2 and/or a weekly dialysis Kt/V urea of greater than 1.7, checked 6-8 weeks after beginning dialysis, should be regarded as minima; the MEAN Kt/V or clearance of a group of patients needed to achieve these minimum figures will be higher, eg Kt/V 1.9-2.0, creatinine clearance 60-65 ml/min. These studies should be repeated at least annually, or if suspicion arises that residual function has declined more rapidly than usual (B).

Values achieved using APD regimens are even less well defined, but almost certainly need to be higher than for CAPD: minima of Kt/V >2.0 and weekly creatinine clearance >60 litres should be aimed for (C).

If an inadequate Kt/V or C cr is identified, it is important to identify the cause(s) (poor compliance, hypercatabolism and malnut­rition, decreased peritoneal clearance or falling residual function) so that appropriate action can be taken. This action may include:

- an increase in the volume of exchanges, eg from 2.0 to 2.5 or even 3.0 litres;

- an extra daily exchange; or

- the introduction of APD. If APD is already in use, a 'wet' day may have to be introduced.

It is often difficult to get patients to accept increases in their dialysis regime, which emphasizes the importance of pushing the treatment to the limit of tolerance at the beginning of dialysis.

If all these measures fail, some patients will need to be transferred from CAPD to HD.

Outpatient monitoring of patients during CAPD

This should include:

  • Assessment of weekly Kt/V and/or creatinine clearance
  • Annual PET measurement, or as indicated clinically
  • Reassessment of prescription in the event of excessive weight gain
  • Collection of biochemical data
  • Assessment of residual renal function annually and as clinically indicated

Residual renal function

As emphasized above, decline in residual renal function has an important bearing on the adequacy of dialysis. Consequently, residual renal function should be assessed at least annually as part of the assessment of total adequacy, or whenever under-dialysis is suspected. [31] The urine collection can also be used to measure urea nitrogen appearance, from which can be calculated the PCR. In steady state, this correlates approximately with dietary protein intake, which should be at least 1.0 g/kg/day.

A significant correlation between Kt/V and PCR is partly a mathematical artifact of the use of V to calculate both parameters [21],[7] it should not be used to assess the impact of adequacy of dialysis on nutrition.

Recommended (B)

In patients with urine output, residual renal function should be measured at least annually.


Peritonitis is the major and most serious complication of CAPD. Apart from the immediate deleterious effects and distress of the acute episode, there is mounting evidence that repeated attacks of peritonitis are associated with earlier failure of the peritoneal membrane. How the frequency of episodes of peritonitis should be measured and expressed remains a subject of contro­versy. In some studies, episodes within a short and variable period of either catheter insertion or beginning dialysis are excluded, and in other studies included. In general an actuarial analysis of time free of peritonitis is the best way to express the peritonitis rate, [2],[32] and we advocate its use, but this has been little used in clinical practice. Despite its theoretical and practical disadvantages, the number of episodes/unit time remains in widest use, and the recommendation below is couched in these terms.

Peritonitis rates are improving with the introduction of disconnect systems. [2],[3] The successful diagnosis and management of peritonitis requires high quality micro­biological facilities and close liaison with the microbiology department. Protocols for managing peritonitis episodes have been published, [33],[34],[35] but it must be noted that the use of vancomycin as a first-line 'blind' antibiotic has been curtailed recently because of the emergence of vancomycin resistant organisms, [36] and alternative regimens have not been evaluated so extensively. [35]

Recommended minimum standard using the disconnect system (A)

Peritonitis rates should be < 1 episode/18 patient-months.

The negative peritoneal fluid culture rate in patients with clinical peritonitis should be less than 10%.

The initial cure rate of peritonitis should be more than 80% (without necessity to remove the catheter).

Peritoneal access

Guidelines for insertion of peritoneal access catheters and their subsequent care have been published by Gokal et al [37] the document advocates the use of these.

Outcome measures and Items for audit

Outcome measures of patients and technique survival are functions of case mix, availability of appropriate dialysis facilities and patient related factors such as age and co-morbidity. Survival data for patients on PD are in general similar to those for HD. [38],[39],[40] As for patients receiving HD, survival is influenced greatly by age and comorbidity, especially diabetes mellitus, and cardiovascular disease.

Possible items for audit of peritoneal dialysis are included in the following list:

Demographic data

Age distribution of patients receiving peritoneal dialysis.


Number of patients on disconnect systems

Numbers on CAPD, APD

Immediate catheter non-function/leak

Catheter survival rate

Correction of anemia

As for hemodialysis

Dialysis adequacy and nutrition

Assessed dietary protein intake frequency distribution, Kt/V; weekly creatinine clearance, Serum albumin, Skin-fold thickness and mid-arm circumference

Correction of biochemical parameters

Serum potassium frequency distribution

Serum bicarbonate frequency distribution

Serum albumin frequency distribution

Blood pressure control

As for hemodialysis

Cardiovascular disease

As for hemodialysis

Transmissible disease

As for hemodialysis.


Peritonitis rate-episodes/patient-month of therapy, Primary cure rate-% (without need to remove catheter), Culture negative rate-%

Exit site infections

Rate- episodes/patient-month of therapy


As for hemodialysis (above)

Temporary transfer (<2 months duration) to hemodialysis

Number and rate

   Recommended Standards for Transplantation Top

Access to transplantation

Demand exceeds supply

Renal transplantation is at the moment the most economical, successful and hence, cost effective treatment for patients with end-stage renal failure (ESRF). The supply of donor organs is greatly outstripped by demand. This gap cannot be closed by using only cadaver kidneys for transplantation. Donor organs are thus, an extremely valuable resource, which must be used optimally. However, it is important also that equity of access to transplantation be achieved, both in geographical terms and for those with uncommon HLA tissue types. The dilemma remains that these two goals are in conflict.

Who should be transplanted?

Not all patients receiving dialysis are suitable for transplantation. There is evidence [41] that selection criteria for placing on the active list for transplantation vary widely throughout the United Kingdom; the proportion of patients maintained on dialysis who are registered with the UKTSSA for renal transplantation varies from 20% in some units to 70% or more. In addition, some units put patients 'on call' who have yet to reach a requirement for dialysis, and these patients receive 'pre­emptive' transplants, competing for kidneys with those already on dialysis, in some cases for many years. This diversity of policy has the disadvantage that it leads to inequity in the distribution of organs, even though it may benefit individual patients.

Suitability for transplantation

In the United States, practice guidelines have been formulated on the basis of consensus and literature review. [42] In the United Kingdom, however, definitive criteria for acceptance on to transplant waiting lists have yet to be agreed, although diabetes, vascular disease and a history of malignant disease are major co-morbid factors that reduce the likelihood of acceptance in many units. This attitude is based on poorer survival of such recipients, and hence of the transplanted kidney (death with a functioning graft).

Although at the moment we cannot recommend standards for investigation of potential transplant recipients, it is essential that appropriate data be collected by pre­transplant investigation to allow definitive criteria to be applied in the future. This applies particularly to cardiovascular disease. Kasiske et al [42] outline the case for investigation of the cardiovascular system in potential transplant recipients and suggest investigative protocols.

Chronological age by itself (at least up to 65-70 years) has been shown in a number of studies not to be a major factor in determining the short-term (<5 years) survival of grafts [43],[44],[45] because an increase in deaths with a functioning graft is counter-balanced by a lower rejection rate in the elderly. However, it is obvious that the outlook for older recipients must be poorer in the long-term (>5 years). To deal with these uncertainties, meetings between transplant staff and dialysis staff need to be held to review patients aged over 55 years annually and those aged over 65 years 6­monthly, because changes in suitability for transplantation may take place. Patients should be placed on, or removed from, transplant waiting lists only after discussion and with the agreement of nephrologists, transplant surgeons and the patients themselves, and recorded in the notes.


There must be demonstrable equity of access to donor organs irrespective of gender, race or district of residence. Age by itself is not a contraindication to transplantation but age related morbidity is important. All patients on dialysis should be considered formally by physicians and surgeons for transplantation, or for exclusion from the transplant waiting list. Their cardiovascular and other co-morbidity should be assessed and recorded. Assessment should be repeated at least annually.

How should kidneys be allocated?

Debate continues on the practical [46],[47] and ethical [48] basis for allocation of kidneys. Ten years ago, in the United States, the United Network for Organ Sharing (UNOS) introduced a formal system of allocating points to potential recipients on a standard scoring system, using such criteria as time waiting for a graft, medical urgency, tissue matching and anti-HLA antibody status. In practice, however, tissue matching has come to be the dominant criterion. In the UK, the system remains very much an adhoc one, varying from region to region in its design and operation. The issue remains crucial but unresolved, and in this document we make recommendations only on the level of tissue matching to be aimed for. This does not mean, however, that it is the only factor that should be taken into consideration in allocating organs.

Organ donation rate

Cadaver organ supply

The total kidney donation rate (cadaver and living donors) in the UK, at 30/million population/year, is exceeded consistently by that in some major European countries such as Austria and Spain, [49],[50],[51] and data are available to suggest that the supply of organs could be increased nationally by approximately 20%. [52] The topic has been discussed extensively in a report of the British Transplantation Society working party, [51] which is in turn discussed by Wight and Cohen, [53] as well as by the King's Fund report. [54] Organ supply is clearly central to expansion of transplantation, the best and most efficient treatment for renal failure. Many topics remain controversial, for example standards for organs to be retrieved, methods of organ preservation and the use of non-heart-beating donors.

Co-operative networks of intensive care units in the hospitals served by the transplant and dialysis units should be developed using transplant co-ordinators, and sustained by educational systems. Currently these services are inadequate and underfunded, [55] and the costs associated with their expansion and improvement, together with formal recognition, will need to be met. Liaison with, and involvement of intensivists and their staff, is crucial.

Living donor transplants

Even a much improved cadaver organ donation rate is unlikely to satisfy the demand, and therefore the need continues for donation by living donors. An important additional justification for living donor transplantation is its superior success rate in comparison with cadaver transplantation. A living organ donation program requires great care to ensure that donation is altruistic, without coercion or reward, that the risks to the donor are minimized, and that the requirements of the Human Organ Transplantation Act [56] are met in all respects. Clearly defined protocols of investigation and management are essential, and such transplants should not be carried out where they constitute an occasional event

The use of motivated but unrelated living donors, such as spouses, unmarried lifelong partners, step-parents or even close friends, remains controversial, although now the results obtained approach those with related living donors and are often superior to those obtained using cadaver grafts. [57] It is likely that the numbers of this type of graft will increase; the provisions of the Human Organ Transplantation Act [56] are specifically designed to prevent abuse in this area.


Services for kidney retrieval must be an integral part of organ transplant services, and costed into them. Purchasers should fund efforts to increase the number of cadaver organs made available, by the setting up of transplant co-ordination and organ procurement teams, to ensure that adequate educational programs are in place; an important aspect of this is improved communication with intensive care units. Thought should be given to ways whereby an ethical expansion of the proportion of living donor organ transplants may be achieved.

The transplant unit


Renal transplantation facilities should be centralized, taking into account geography, population density and communications. This avoids duplication of specialized resources such as histocompatibility laboratories and organ retrieval teams, and permits training of medical and other staff.

Ward facilities

The transplant unit should have six dedicated beds per million population (pmp) served for new transplants, one-third of which must be single-bed cubicles. This figure may need to be varied in the light of geography, communication networks and population density. Dialysis, as needed, should be possible at all stations. Beds must be within a single ward to ensure high standards of training, nursing and cross-infection care, though all the beds in the ward need not be devoted to transplantation.

Support services

Full support is essential, including access to operating theatres 24 hours a day, to allow prompt transplantation of incoming cadaveric kidneys, to minimize the cold ischemic time. [58],[59] Elective operating theatre facilities will also be needed. Laboratory support is essential, including histocom­patibility and antibody testing. A full hematology and biochemistry service is needed, including blood grouping and provision, where necessary, of cytomegalo­virus (CMV) negative blood. Pharmaco­logical assays will also be needed for immunosuppressive and some other drugs. There must be immediate and continuous access to virology and bacteriology services, including screening for CMV antibody and antigen (PCR), HIV, hepatitis B and C, and histopathology services with a specialist histopathologist trained in the interpretation of renal transplant biopsies.


Facilities to which access is essential are routine X-ray, conventional ultrasound plus Duplex ultrasound for vascular imaging, computed tomography (CT) and radioisotope scanning, angiography and the services of an interventional radiologist. Magnetic resonance imaging (MRI) is not essential at the moment, but access will be needed for a few patients. It is important to emphasize that these services will often be required at short notice and out of normal working hours.

Other medical and surgical disciplines

Access to urology services and advice is necessary. Since vascular disease is common both in prospective recipients and after transplantation, the transplant unit needs access to full clinical and investigational cardiological assessment, including coronary angiography and thallium dipyridamole scanning. Joint management of diabetic patients with a diabetologist is desirable before and after transplantation. Access to other specialties such as neurology, gastro­enterology, thoracic medicine and infectious disease will be needed on occasion for acute consultation. Long-term morbidity in transplant recipients involves a high incidence of skin lesions, some of them malignant, and the advice of a derma­tologist will be needed on a regular basis.


Patients should be followed in the transplant centre for at least three months following transplantation. Consultant led clinics will be needed for this, although junior staff should participate under supervision, as may nurse practitioners. The number of patients attending the transplant clinic will depend upon the number of transplants performed, the success rate, and the policy with regard to discharge back to local nephrologists/physicians. All recipients should be reviewed at least annually at the transplant centre unless the facilities in the dialysis units served, and the ability to transfer data centrally, make this unnecessary. Living donors should be followed also on an annual basis, since they have a higher incidence of proteinuria and hypertension than control populations. Renal function should be assessed at each visit. Donors may also need counseling, especially if the transplant has been a failure, and this should be available.

Data storage and access

This is essential for both clinical and service audit; both staff and equipment must be costed into the service. The database should be interfaced with the UKTSSA, which is integrated with the National Renal Registry. If patients are referred back for continuing care to local nephrologists, the local databases must be linked to the transplant unit.


It would not be appropriate in this document to go into staffing in detail. However, there should be at least four surgeons trained in transplantation per two million population, plus appropriate support staff {consultant rotas should not be more than 1:4}. Cross­cover by surgeons untrained in transplan­tation is undesirable and, where such rotas exist, should be phased out by alliances with adjacent units. The presence of only a single-handed consultant transplant surgeon is to be condemned.

Integration with transplantation of other organs

Multiple organ donation continues to increase, and organ retrieval services must be designed with this in mind. A number of diabetic patients will have kidney-pancreas transplants, and these will in general be managed within transplant units but with input from diabetic specialists. Occasionally, recipients will receive kidney-liver and kidney-heart transplants, and the site of their management may vary. The services for these patients must be sited and administered with care, and joint management in transplant centers performing multiple transplants is desirable.

Recommendation (C)

Transplant units should in general serve at least two million total populations, depending upon geography, communications and population density. They must be appro­priately located, and perform at least 50 transplants per year except where geography dictates the need for a smaller unit.

Transplant units must be adequately staffed both medically and surgically, with training opportunities for junior staff, and have full support services. Full integration with dialysis services and regular contact with physicians in joint care of transplant patients is essential.

Histocompatibility matching and allocation of donor kidneys

The tissue typing laboratory should be directed by a medical consultant or consultant clinical scientist who is in charge of the day-to-day laboratory activity and is available for contact outside normal working hours. The laboratory must meet Clinical Pathology Accreditation standards, and must be actively involved in research and development.

Technical developments in laboratory aspects of kidney transplantation have been dramatic and are likely to continue. The advent of molecular biological techniques has had a significant impact on the quality of HLA matching, and interpretation of crossmatch results from various techniques has enabled many patients to receive a successful transplant. The BSHI has estab­lished standard descriptions of currently available techniques which clinicians should adopt when requesting tests.

The regulations incorporated in the Human Organ Transplantation Act [56] specify that, in living donor transplantation, tissue typing tests are to be carried out by an 'approved tester', appointed by the Department of Health, to establish a claimed genetic relationship. When there is no claimed genetic relationship or when such a relationship cannot be established, the case must be referred to the Unrelated Live Transplant Regulatory Authority (ULTRA) via the ULTRA Secretariat at the Department of Health.

Approved testers must be fully aware of their responsibilities under the regulations, including receipt of signed statements claiming a relationship, documented blood samples, completion of specified tests, recording and long-term storage of test results and formal reporting. Testers must be aware of the limitations of the specified tests and should report accordingly. The penalties defined in the Act should be understood.

Recommended standard

An efficient, high quality tissue typing service must be seen as an essential part of a successful kidney transplant program.

Cadaver kidneys must be allocated on the basis of matching for HLA alloantigens and crossmatching supported by efficient antibody screening (A).

Living donor kidneys and recipients must be typed by an 'approved tester' appointed by the Department of Health.

The tissue typing laboratory staff must be an integral part of the transplant team.

Tissue matching in transplantation

Identity or compatibility of ABO blood groups between donor and recipient currently is essential. The principle of matching the donor kidney tissue type (HLA-or allo-antigens) to that of the recipient to optimize transplant outcome and minimize rejection is well established and has been practiced by UK units since 1978. Matching is especially important in determining longer-term (5-15 years) outcomes. [60],[61]

Beneficial matching

A 'beneficial' match is defined as no mismatches for HLA-DR with a maximum of one mismatch at either of HLA-A or -B. (A:B:DR 000 or 100 or 010). Analyses by the UKTSSA have shown superior graft survival of beneficially matched kidneys, but no effect of matching between the various other grades of mismatch. [62],[63],[64] In the UK about 30% of cases are 'beneficially' matched, and the remainder are allocated to recipients on the basis of a number of factors, including a minimum HLA match, time on the waiting list and, in some units, the relationship between donor and recipient ages. Thus, a major aim is to restrict total mismatches. Patients with high levels of antibodies specific for previously mismatched HLA allo-antigens can join the 'acceptable mismatch' scheme which aims to provide donor kidneys to patients for whom matching and cross-matching are difficult.

Mismatches for common HLA antigens should be avoided wherever possible in young recipients, who may thus acquire HLA-specific antibodies against a high proportion of potential donors, and make re-transplantation difficult should their graft fail.

Recommended standard (A)

Beneficial matching of donor kidneys should be achieved in a minimum of 30% of recipients.


Immediate, 'hyperacute' rejection of transplanted kidneys can be prevented by performing a crossmatch between recipient serum and donor lymphocytes. Since 1965, the techniques available to detect interaction of recipient antibody and donor target antigen and the interpretation of crossmatch results have been greatly extended. There are many different techniques used in different centers, and different policies on how the outcome of the crossmatch is used. Each centre should establish its own policy based on published data and local experience, but a crossmatch must always be performed prior to kidney transplantation.

The value of crossmatching by flow cytometry (FC) has become apparent recently, particularly in recipients at high-risk of rejection such as children and patients with high levels of circulating antibody or previous transplantation, but careful standardization and quantification of the results are necessary. [65],[66]

Recommended standard (B)

All donor-recipient pairs should be cross­matched by an acceptable technique before transplantation. FC crossmatching should be available for re-transplants, children and highly sensitized recipients.

Screening for antibodies in recipients

Efficient HLA matching and cross­matching procedures should be used with a screening program to detect HLA-specific antibodies. Sensitized patients are those who have been exposed to HLA (allo-antigen) through pregnancy, blood transfusion or a previous transplant, and who may have HLA-specific antibodies detectable in their serum. Blood group antigens other than ABO rarely give problems, with the exception of the Lewis (Lew) group.

The definition of sensitization depends crucially upon the techniques used. The assay most widely used is the complement dependent cytotoxicity assay using lympho­cytes as the target cells. A cell panel of at least 20 cells from different donors may be sufficient to cover most HLA specificities, but most laboratories use larger numbers (50-75) of test donors. The panel must be carefully selected to contain HLA specificities (HLA-A, -B, -Cw, -DR, -DQ ) occurring in combinations that allow efficient interpretation of results. Although the degree of reactivity to the panel is often expressed as a percentage, this is misleading since the panel is chosen to represent a wide range of antigens and not the population as a whole. Recently, tests based on ELISA (enzyme-linked immunosorbent assay) and FC have become available, with benefits of increased sensitivity and specificity. Assays used to detect allo-sensitization must have a sensitivity equivalent to crossmatching techniques.


All screening for HLA-specific antibodies should use a typed panel of donor cells which allow interpretation of positive reactions.

All potential transplant recipients should be screened for HLA-specific antibodies, two weeks after any blood transfusion (B).

All potential recipients should be screened at least four times a year for HLA-specific antibodies (C).

The tissue type of fathers of children borne by female potential recipients should be determined wherever possible.

Highly sensitized recipients

Conventionally, highly sensitized patients (HSPs) are defined as those who react with more than 85% of panel cells. To qualify as an HSP, the potential recipient must be shown to have IgG antibodies specific for allo­antigens, most often for several HLA-A, -B or -Cw specificities, usually those common in the donor population. Autoreactive IgM antibodies may give the impression of high panel reactivity, but since these antibodies do not prevent successful transplantation their presence must be carefully defined. However, recent evidence suggests that IgM HLA-specific antibodies do occur, and may be deleterious, so simple in vitro destruction of IgM antibodies before testing is not recommended.

Evidence of sensitization in the form of circulating antibodies varies with time, so serum samples must be taken within two weeks of any blood transfusion, in the immediate post-transplant period, and in all patients on the transplant waiting list at least quarterly. Ideally, the HLA phenotypes of the father(s) of all past pregnancies should be available. All HLA specificities against which the potential recipient may react should be recorded as 'unacceptable antigens', and should be avoided in the transplant kidney.

Some HSPs can be shown not to react with certain specificities; these should be recorded as 'acceptable mismatches'. Survival of HLA mismatched kidneys in HSPs is generally poor, whereas well matched kidneys survive well, and therefore 'beneficially' matched kidneys should usually be allocated. HSPs are high-risk recipients, and so should receive optimum transplants.

Recommendation (B)

Highly sensitized recipients should have their serum screened for HLA-specific antibodies, the specificities of which should be defined carefully. They should receive kidneys that bear only matched antigens (or 'acceptable' mismatches).

After transplantation

If antibody screening is carried out regularly after transplantation, accurate cross-matching for re-transplantation can help achieve success rates after re-transplantation as good as those for first transplants.

Recommendation (C)

Following transplantation, it is essential that the tissue-typing laboratory continue to receive serum samples for antibody screening at each clinic visit.

Interaction between laboratory and clinicians

Transplantation is a multi-disciplinary clinical service and the best success rates can be achieved only through close liaison of laboratory and clinical staff. Highly trained and dedicated staff in a histo­compatibility laboratory must meet with clinical colleagues regularly and must provide a 365 day, 24 hour service.

Immunosuppressive regimens

At the moment there are insufficient data to permit specific recommendations on immuno­suppressive regimens of monotherapy, double or triple therapy using prednisolone, aza­thioprine, cyclosporin microemulsion (Neoral TM), tacrolimus (FK 506) or mycophe­nolate mofetil. Nor is the role of protein immunosuppressants (antilymphocyte globulin, OKT3 etc) clear. At the moment, the most commonly used regimen for the first year after transplantation is triple therapy with prednisolone, azathioprine and cyclosporin, but it is likely that mycophenolate mofetil and/or tacrolimus will become increasingly used during the next few years because the number of early rejections under regimens using these drugs appears to be lower, and lower rates of early rejection in turn are correlated with better long-term function and graft survival.

Graft survival and incidence of rejections appear to be similar with regimens in wide current use, except that graft survival is lower and rejection more common with regimens containing only prednisolone and azathioprine compared with those containing cyclosporin, [67] and newer agents. However, morbidity (e.g. infection and skin cancers) may well differ and early rejection rates are lower with the newer drugs (mycophenolate mofetil and tacrolimus). It is likely that a greater diversity of regimens will be used in future to 'tailor' therapy more accurately to individual patients' needs.

New agents such as mycophenolate and tacrolimus are under trial, and only further controlled studies will allow any recom­mendations to be made. Until these are completed, outcomes need careful auditing to allow accumulation of informative data. The choice of immunosuppressive regimen has substantial cost implications, which will need discussion with purchasers, but the high costs of a failed graft must be borne in mind also; cost effectiveness data are needed urgently in this area.

Standards of outcome in transplantation

At the moment recommended standards can be set for patients without major comorbidity and whose ages lie between 15 and 50 years of age. The figures suggested below are minimum acceptable results for cadaveric transplantation. Organ retrieval rate

In 1992-3 the mean cadaver organ donor rate in the UK was 15 donors per million per year.

Recommended standard

At least 15 donors/million population/year should be retrieved.

The mean figure in the UK in 1992-3 was 28 cadaver donor kidneys pmp.

Recommended standard

Each transplant unit should transplant at least 28 patients/million population/year with cadaver kidneys.

Cold ischemic times

Lengthy cold ischemic times (>30 h) are associated with inferior graft survival in some studies, [58] and this is supported by unpublished data the UKTSSA and Euro­transplant databases.

Recommended standard (B)

Efforts should be made to limit the cold ischemic time to less than 30 hours in all cases.

Number of live donor transplants

The UK mean is 2 pmp per year, whilst in several European countries it is more than 5 and in Norway exceeds 17 pmp.

Recommended standard

Each transplant unit should transplant a minimum of 2 living donor grafts pmp/year, but it is hoped that a higher standard than this can be set in the near future.

Waiting time on transplant list

The median waiting time in the UK is 500 days, but differs markedly for sensitized and unsensitized patients, and is affected also by age, previous grafting and blood group. Of patients on the UK transplant waiting list, 13.5% have been waiting more than 5 years, and 18% of these patients are not sensitized.

Recommended standard

Not more than 2% of non-sensitized patients should wait more than 5 years for a graft.

Selection for transplantation

Policies vary from unit to unit as to which patients, and what proportion, are placed on transplant call but the UK mean is 30%. Naturally there will be variation according to the case-mix of patients on dialysis, and particularly their comorbidity and age. In this area, equity and optimum use of the scarce resources of transplantable kidneys are in conflict.

Recommended standard

At least 30% of dialysis patients in any unit should be on the transplant waiting list and there should be regular review of the on-call transplant list.

Beneficial matching

Currently only 25% of recipients in the UK receive a beneficial match.

Recommended standard (B)

At least 30% of recipients should receive a beneficial major histocompatibility complex (MHC) matched kidney.

Time of onset of renal function

The mean rate of achieving immediate renal function in the UK is 68%, and is dependent upon the types of kidney accepted for use, and their handling within the transplant unit. It is known that kidneys with immediate function do better in the long-term. In the UK, 5% of kidneys never function.

Recommended standard (B)

At least 70% of heart beating cadaver transplants should function immediately and at least 95% should function eventually.

Patient survival in cadaver transplants

The following are overall figures for the UK for first cadaver transplants formed from 1984 to 1993 and the recommended standards.

Recommended standard (B)

Graft survival in cadaver transplants

The following are overall figures for the UK for first cadaver transplants performed from 1984 to 1993 and the recommended standards.

Recommended standard (B)

Second and subsequent grafts

Recommended standard (B)

Graft survival of second grafts should be the same as for first grafts, provided that adequate analysis of allo-antibodies and FC crossmatching are used. Patient survival with living donor

Recommended standard (B)

There should be at least 95% survival at 1 year after grafting

Graft survival with living donor

Recommended standard (B)

More than 90% of grafts should still be working at one year.

Patients with co-morbid conditions

It will remain much more difficult to set targets for transplant recipients with diabetes mellitus and/or significant comorbidity until some standard way of describing this and assessing the risk has been achieved. In the future it should be possible to set standards for these patients.

Clinical outcomes and items for audit

Clinical and medical audit should be an integral part of the work of the transplant unit. Patient survival, morbidity and transplant outcomes depend critically upon a number of case-mix factors such as the age and co­morbidity of the population transplanted. This in turn depends upon the criteria for the selection process applied locally first for selecting those on dialysis as potential transplant recipients, and more remotely on the criteria for acceptance on to dialysis itself.

Recommended standard

A list of items that should be regularly audited before and after transplantation is included below.

All the data should be entered into the UKTSSA database in Bristol, so that they can contribute to, and be compared with, national and international data.

The following list contains items that can be subjected to audit before and after renal transplantation.


Number of organ donors each year/million population.

Number of renal transplants performed per million population per annum, both cadaver and living, related and unrelated.

Proportion of patients on dialysis entered on to the transplantation waiting list. Waiting time of patients on dialysis.

Equity of access to: (a) the transplant waiting list; (b) transplanted kidneys (Particular attention should be paid to patients from ethnic minorities and older patients, and the age range on the transplant waiting list should be reviewed).

Number of patients on the transplant waiting list and their degree of sensitization against common HLA antigens.

Proportion of patients receiving a 'beneficial match' kidney.

Number of kidneys that are unsuitable for use because of their anatomy or damage during retrieval.

Early (first year) post-transplant

Cold storage times of transplanted kidneys.

Proportion of cadaver transplant recipients with immediate function, delayed function and failure of function.

Number of days of hospitalization in the first and subsequent years after transplantation.

Proportion of patients with urological problems after grafting.

Proportion of patients with renal vascular problems after grafting.

Incidence of wound infections after transplantation.

Number of other serious infections (abscesses, septicemia, serious fungal or viral disease) in the post-operative period and later.

Proportion of patients with one or more histologically diagnosed rejection episodes in the first 3 months.

Percentage of these episodes that were resistant to corticosteroid treatment.

Incidence of graft loss from acute rejection in the first 3 months.

Plasma creatinine concentration in those with functioning grafts.

Incidence of death with a functioning graft in the first 3 months.

Long-term post-transplant

Frequency and causes of death.

Frequency and attributed causes of graft failure.

Plasma creatinine concentration in those with functioning grafts.

Prevalence of hypertension requiring treatment.

Prevalence of cardiovascular events and disease.

Plasma cholesterol (Whether it is useful to measure and/or treat raised plasma cholesterol concentrations post-transplant remains contro­versial. Until the results of long-term controlled trials are available, plasma cholesterol should be measured annually to allow correlation with outcome).

Prevalence of malignant disease of all types, including skin cancers.

Number of pregnancies, spontaneous and therapeutic abortion rates and complications of pregnancy (e.g., Cesarian section rate).

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Correspondence Address:
Ibrahim Hassan Fahal
Oldchurch Hospital, Waterloo Road, Romford, Essex, RM7 0BE
United Kingdom
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PMID: 18209374

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