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Guideline Summary
Guideline Title
Kidney donation. In: Guidelines on renal transplantation.
Bibliographic Source(s)
Kidney donation. In: Kälble T, Alcaraz A, Budde K, Humke U, Karam G, Lucan M, Nicita G, Süsal C. Guidelines on renal transplantation. Arnhem, The Netherlands: European Association of Urology (EAU); 2009 Mar. p. 7-29. [139 references]
Guideline Status

This is the current release of the guideline.

Scope

Disease/Condition(s)

Kidney diseases requiring kidney transplantation

Guideline Category
Counseling
Evaluation
Management
Risk Assessment
Screening
Clinical Specialty
Nephrology
Surgery
Urology
Intended Users
Advanced Practice Nurses
Allied Health Personnel
Hospitals
Nurses
Physician Assistants
Physicians
Psychologists/Non-physician Behavioral Health Clinicians
Guideline Objective(s)
  • To present current knowledge about renal transplantation
  • To provide policies for increasing the supply and use of deceased donors and enhancing living donation
  • To provide recommendations for the assessment and selection of donors (living and deceased) as well as for explantation technique and organ preservation
Target Population
  • Living and brain-dead kidney donors
  • Patients requiring kidney transplantation
Interventions and Practices Considered
  1. Ethical and legal issues related to kidney donation and transplantation
  2. Policies to increase the supply and use of deceased donors
  3. Polices to enhance living donation
  4. Kidney donor selection and refusal criteria
  5. Kidney recovery and explantation technique
    • Deceased donor
    • Living donor
      • Exclusion criteria
      • Open vs laparoscopic technique
  6. Organ preservation
Major Outcomes Considered
  • Kidney donation rates in Europe
  • Kidney transplantation rates in Europe
  • Efficacy and safety of laparoscopic living-donor nephrectomy
  • Long- and short-term kidney allograft survival rates
  • Complications of live-donor nephrectomy

Methodology

Methods Used to Collect/Select the Evidence
Searches of Electronic Databases
Description of Methods Used to Collect/Select the Evidence

A structured literature search is performed for all guidelines but this search is limited to randomised controlled trials and meta-analyses, covering at least the past three years, or up until the date of the latest text update if this exceeds the three-year period. Other excellent sources to include are other high-level evidence, Cochrane review and available high-quality guidelines produced by other expert groups or organizations. If there are no high-level data available, the only option is to include lower-level data. The choice of literature is guided by the expertise and knowledge of the Guidelines Working Group.

Number of Source Documents

Not stated

Methods Used to Assess the Quality and Strength of the Evidence
Weighting According to a Rating Scheme (Scheme Given)
Rating Scheme for the Strength of the Evidence

Level of Evidence

1a Evidence obtained from meta-analysis of randomised trials

1b Evidence obtained from at least one randomised trial

2a Evidence obtained from at least one well-designed controlled study without randomisation

2b Evidence obtained from at least one other type of well-designed quasi-experimental study

3 Evidence obtained from well-designed non-experimental studies, such as comparative studies, correlation studies and case reports

4 Evidence obtained from expert committee reports or opinions or clinical experience of respected authorities

Methods Used to Analyze the Evidence
Review of Published Meta-Analyses
Systematic Review
Description of the Methods Used to Analyze the Evidence

Not stated

Methods Used to Formulate the Recommendations
Expert Consensus
Description of Methods Used to Formulate the Recommendations

General Methods Used to Formulate the Recommendations

  • The first step in the European Association of Urology (EAU) guidelines procedure is to define the main topic.
  • The second step is to establish a working group. The working groups comprise about 4 to 8 members, from several countries. Most of the working group members are academic urologists with a special interest in the topic. Specialists from other medical fields (radiotherapy, oncology, gynaecology, anaesthesiology, etc.) are included as full members of the working groups as needed. In general, general practitioners or patient representatives are not part of the working groups. Each member is appointed for a four-year period, renewable once. A chairman leads each group.
  • The third step is to collect and evaluate the underlying evidence from the published literature.
  • The fourth step is to structure and present the information. All main recommendations are summarised in boxes and the strength of the recommendation is clearly marked in three grades (A–C), depending on the evidence source upon which the recommendation is based. Every possible effort is made to make the linkage between the level of evidence and grade of recommendation as transparent as possible.

Specific Methods Used for This Guideline

As renal transplantation is very much an interdisciplinary field, the Guidelines Group contains not only urologists but also an immunologist and a nephrologist. Besides medical and technical aspects, the Guidelines Group has also considered ethical, social and political aspects. This was necessary because of the still-increasing gap between 'supply' and 'demand' for kidney transplants, and the large differences in organ donation rates between several European countries, suggesting European countries can learn from each other on how to increase organ donation rates.

There are few prospective randomised studies for most sections of the Guidelines, and sometimes none. Thus, the grades of recommendation, which are evidence-based, seldom exceed grade C. Instead, the Guidelines are well supported by a wealth of clinical experience based on several decades of work in renal transplantation, as in, for example, technical aspects of transplantation and explantation.

A level of evidence and/or grade of recommendation have been assigned where possible. The aim of grading recommendations is to provide transparency between the underlying evidence and the recommendation given.

Rating Scheme for the Strength of the Recommendations

Grade of Recommendation

  1. Based on clinical studies of good quality and consistency addressing the specific recommendations and including at least one randomised trial
  2. Based on well-conducted clinical studies, but without randomised clinical trials
  3. Made despite the absence of directly applicable clinical studies of good quality
Cost Analysis

A formal cost analysis was not performed and published cost analyses were not reviewed.

Method of Guideline Validation
Internal Peer Review
Description of Method of Guideline Validation

There is no formal external review prior to publication.

The Appraisal of Guidelines for Research and Evaluation (AGREE) instrument was used to analyse and assess a range of specific attributes contributing to the validity of a specific clinical guideline.

The AGREE instrument, to be used by two to four appraisers, was developed by the AGREE collaboration (www.agreecollaboration.org External Web Site Policy) using referenced sources for the evaluation of specific guidelines. (See the "Availability of Companion Documents" field for further methodology information.)

Recommendations

Major Recommendations

Note from the European Association of Urology (EAU) and the National Guideline Clearinghouse (NGC): The following recommendations were current as of the publication date. However, because EAU updates their guidelines frequently, users may wish to consult the EAU Web site External Web Site Policy for the most current version available.

Grades of recommendation (A–C) are defined at the end of the "Major Recommendations" field.

Ethical Issues in Transplantation

  • It is the right of individuals to donate as well as to receive an organ.
  • Commercially motivated renal transplantation is unacceptable. It has been widely prohibited by law and is strongly opposed by the International Society of Transplantation.
  • With the increasing success of living-donor transplants, as judged by graft and patient survival, and with the scarcity of deceased donor organs, living-donor transplants should be encouraged.
  • The appeal of using living donors in renal transplantation is partly due to the ongoing shortage of deceased donors.
  • The altruistic living donor must give informed consent, which can only be obtained if he or she has a proper understanding of the risk involved.
  • A patient should be treated as an 'end', and not as a 'means'. Respect for dignity, integrity and authenticity of the person are basic human rights.
  • Living unrelated donors should only be accepted after the local ethical committee has given permission according to the rules of the country in which the donation is taking place.

Policies to Increase the Supply and Use of Deceased Donors

  • In all countries without presumed consent law, efforts should be increased to recruit donors through an opting-in register or by carrying donor cards. (Grade of recommendation: C)
  • Professional organisations within countries should, where necessary, put pressure on government health departments to maintain enough intensive care beds, create a cadre of national transplant co-ordinators and fund and deploy educational programmes for intensive care physicians. (Grade of recommendation: C)
  • A recommendation cannot be made about something as fundamental as changing the law on deceased donor donation.
  • However, presumed consent with an opting-out law is desirable.
  • Greater use of non–heart beating donors (NHBDs) should be made. (Grade of recommendation: B)
  • Transplant staff should create policies for recently dead admissions to casualty departments to be used as NHBDs. (Grade of recommendation: B)
  • Local coroners should be consulted regarding the legal implications. (Grade of recommendation: B)
  • The use of carefully selected donors over 60 years should be maintained and encouraged as a continuing source of deceased donor kidneys. (Grade of recommendation: B)
  • Donors over 70 should be evaluated on an individual basis, taking into account that better results are obtained when transplanted to patients older than 60 years. (Grade of recommendation: B)

Policies to Enhance Living Donation

  • Living donation in Europe should be encouraged. There is a widening gap between donation and demand for kidney transplants, with not enough deceased donors. There is, however, an increase in living donors. In the USA, the number of kidneys from living donors is nearly the number of kidneys from deceased donors. (Grade of recommendation: C)
  • Organ donation should be considered a charitable gift. Society can express gratitude to organ donors for their gift as with charitable contributions, without jeopardising its altruistic basis (e.g., 'Medal of Honor', limited reimbursement, medical leave, priority access to organ for transplant, donor insurance). (Grade of recommendation: C)
  • All nephrologists who care for end stage renal disease (ESRD) patients should explore the living donor option with the family when a patient first presents with ESRD.
  • Multiple renal artery or grafts with anatomical anomalies are not absolute contraindications. Decisions should be made on an individual basis. (Grade of recommendation: C)
  • Laparoscopic right kidney nephrectomy is as safe as left nephrectomy in terms of complications and graft survival. (Grade of recommendation: A)
  • Laparoscopic nephrectomy offers equal urological complications, graft function and graft survival than open nephrectomy, with less post-operative morbidity, shorter convalescence and better cosmetic results. (Grade of recommendation: A)
  • Laparoscopic nephrectomy increases the number of individuals willing to donate. It should be used only by appropriately trained and experienced surgeons. (Grade of recommendation: C)
  • ABO-incompatible transplantation is a promising procedure undergoing clinical evaluation. (Grade of recommendation: C)
  • It should be performed in experienced centres under scientific documentation. (Grade of recommendation: C)
  • Patients should be counselled about potential risks and alternatives. (Grade of recommendation: C)
  • Transplantation of cross-match positive living donors is an experimental procedure, which should only be performed in scientific trials. Patients should be counselled about risks and potential alternatives. (Grade of recommendation: C)
  • Living related and unrelated donation should be encouraged within national laws. (Grade of recommendation: B)
  • Legislation in every European country forbids payment for organs. (Grade of recommendation: C)
  • Donation of an organ should remain a "gift of life" without any financial impetus. (Grade of recommendation: C)
  • Paired kidney exchange if permitted by national law is a way of increasing the number of kidney transplants. (Grade of recommendation: C)
  • The health and well-being of living donors should be monitored in a follow-up register to document any long-term medical problems due to donation. (Grade of recommendation: B)
  • There should be a national insurance plan that provides life and disability insurance for all living donors. (Grade of recommendation: B)

Kidney Donor Selection and Refusal Criteria

  • Any brain dead comatose subject should be considered a potential organ donor, without age limits. (Grade of recommendation: C)
  • Consensus for organ harvesting should be obtained from relatives or significant others according to local law and policies. Authorisation for explantation by the donor's close relatives is always recommended, even if local legislation on organ donation presumes consent:
    • Contact between relatives and a well-trained, sensitive professional is very important in establishing favourable public opinion on organ donation.
    • Individuals who objected to donation during life must always be excluded.
  • Any donor organ affected by a potentially transmittable pathology (infections, neoplasias) must be carefully evaluated considering the risk-benefit ratio for the recipient. (Grade of recommendation: B)
  • A good-quality organ must be guaranteed to the recipient and every transplant centre must establish its own guidelines on organ acceptability. Organs from marginal donors can only be used after thorough assessment. The recipients need to be informed and must confirm their acceptance. (Grade of recommendation: C)

Explantation Technique

Deceased Donors

  • Kidneys are the last organs to be recovered in multiple organ recovery. Appropriate placement of the aortic cannula for the cold 'in-situ' flush is essential. (Grade of recommendation: C)
  • After retrieval of the thoracic organs and liver, and if the pancreas is to be removed, the liver and pancreas should be recovered en bloc and separated on the back table. (Grade of recommendation: B)
  • In multiple organ recovery, it is essential there is good co-ordination and co-operation between the surgical teams. (Grade of recommendation: C)

Living Donors

  • The use of living donors has been associated with higher success rates than seen with deceased donor donation. Living donation allows some patients to avoid long waiting times and even dialysis. (Grade of recommendation: B)
  • An independent assessment of the donor's renal function by a nephrologist or a specialised team is mandatory in all cases. (Grade of recommendation: B)
  • It is advisable to obtain a psychiatric or independent medical evaluation of the donor's motivation, fitness and his ability to understand the risks of the operation. (Grade of recommendation: B)
  • It is the surgeon's responsibility to ensure that the donor is medically, as well as psychologically, suitable for the procedure; the donated organ is healthy; and the expectation of success in the recipient is reasonable. (Grade of recommendation: B)
  • The donor should always be left with the 'better' kidney. Kidney removal through a transperitoneal approach has a higher number of splenic and intestinal complications compared with other surgical alternatives.
  • Open-donor nephrectomy should be performed by an extraperitoneal approach through a subcostal or dorsal lumbotomy incision. (Grade of recommendation: B)
  • Laparoscopic donor nephrectomy (either trans- or retroperitoneal) should only be performed by those trained in the procedure. (Grade of recommendation: B)
  • Hand-assisted laparoscopic donor nephrectomy minimises warm ischaemia time compared to classic laparoscopic procedures. (Grade of recommendation: B)

Organ Preservation

  • University of Wisconsin (UW)-solution and histidine-tryptophane-ketoglutarate (HTK)-solution are standard storage solutions and equally effective for both multiorgan-donors and kidney-only donors. (Grade of recommendation: A)
  • Celsior-solution seems to be equally effective. (Grade of recommendation: B)
  • Keep cold and warm ischaemia times as short as possible for any renal transplant. (Grade of recommendation: A)

Definitions:

Grades of Recommendation

  1. Based on clinical studies of good quality and consistency addressing the specific recommendations and including at least one randomized trial
  2. Based on well-conducted clinical studies, but without randomized clinical trials
  3. Made despite the absence of directly applicable clinical studies of good quality
Clinical Algorithm(s)

None provided

Evidence Supporting the Recommendations

Type of Evidence Supporting the Recommendations

The type of supporting evidence is identified and graded for selected recommendations (see "Major Recommendations").

Benefits/Harms of Implementing the Guideline Recommendations

Potential Benefits

General

  • Improved standards for kidney donor assessment and selection
  • Improved allocation of donor organs
  • Increased deceased- and live-donation rates
  • Improved organ preservation
  • Improved outcomes in kidney transplant recipients

Advantages of Living Donation

  • Better results (both long- and short-term) compared to deceased donor grafts
  • Consistent early function and easier management
  • Avoidance of long waiting time for transplantation
  • Less aggressive immunosuppressive regimens
  • Emotional gain to donor
  • Increases globally the kidney transplant rate
Potential Harms

Open Live-donor Nephrectomy

Postoperative complications and morbidity

Laparoscopic Live-donor Nephrectomy

  • Graft loss or damage during "learning curve"
  • Pneumoperitoneum may compromise renal blood flow
  • Longer operative time
  • Postoperative complications and morbidity

Elderly Donors

The short-term results of transplants with kidneys from donors over 65 years old are almost similar to those with younger organs. However, long-term graft survival is lower. In addition, the main physiological risk factor in 'older' kidneys is a prolonged cold ischaemia time.

Human Immunodeficiency Virus (HIV) Transmission

There is a high risk of HIV transmission from potential donors with suspected intravenous drug abuse. In addition, serology tests during the incubation period of HIV (2 months) or hepatitis (up to 6 months) may be negative, while large amounts of fluids administered during a resuscitation attempt can result in a normal serology due to dilution effects. Serological tests must therefore be repeated and additional tests done (e.g., polymerase chain reaction) to rule out infection.

Contraindications

Contraindications

Exclusion Criteria for Living Donors

Relative Contraindications

  • Use of grafts with anatomical anomalies
  • Active chronic infection (e.g., tuberculosis, hepatitis B/C, parasites)
  • Obesity
  • Psychiatric disorders

Absolute Contraindications

  • Age <18 years
  • Uncontrolled hypertension
  • Diabetes mellitus
  • Proteinuria (>300 mg/24 h)
  • Abnormal glomerular filtration rate (GFR) for age
  • Microscopic haematuria
  • High risk of thromboembolism
  • Medically significant illness (chronic lung disease, recent malignant tumour, heart disease)
  • History of bilateral kidney stones
  • Human immunodeficiency virus (HIV) positive

History of Malignancy

A previous history of malignancy is not usually a contraindication for organ donation. However, there are some absolute contraindications that make a donor unsuitable for transplant. These are active cancer or a history of metastatic cancer (with a few exceptions, such as testicular cancer) and cancers with high recurrence rates, such as advanced breast carcinoma, melanoma, leukaemia, or lymphoma. In addition, when a potential donor has experienced a brain haemorrhage of unknown aetiology, metastasis must be excluded as a cause of intracranial bleeding.

Qualifying Statements

Qualifying Statements

As attitudes and practice to renal transplantation vary significantly, these guidelines provide general guidance only.

Implementation of the Guideline

Description of Implementation Strategy

The European Association of Urology (EAU) Guidelines long version (containing all 19 guidelines) is reprinted annually in one book. Each text is dated. This means that if the latest edition of the book is read, one will know that this is the most updated version available. The same text is also made available on a CD (with hyperlinks to PubMed for most references) and posted on the EAU websites Uroweb and Urosource (http://www.uroweb.org/guidelines/online-guidelines/ External Web Site Policy and http://www.urosource.com/diseases/ External Web Site Policy).

Condensed pocket versions, containing mainly flow-charts and summaries, are also printed annually. All these publications are distributed free of charge to all (more than 10,000) members of the association. Abridged versions of the guidelines are published in European Urology as original papers. Furthermore, many important websites list links to the relevant EAU guidelines sections on the association websites and all, or individual, guidelines have been translated to some 15 languages.

Implementation Tools
Foreign Language Translations
Pocket Guide/Reference Cards
Resources
For information about availability, see the Availability of Companion Documents and Patient Resources fields below.

Institute of Medicine (IOM) National Healthcare Quality Report Categories

IOM Care Need
Living with Illness
Staying Healthy
IOM Domain
Effectiveness
Patient-centeredness
Safety

Identifying Information and Availability

Bibliographic Source(s)
Kidney donation. In: Kälble T, Alcaraz A, Budde K, Humke U, Karam G, Lucan M, Nicita G, Süsal C. Guidelines on renal transplantation. Arnhem, The Netherlands: European Association of Urology (EAU); 2009 Mar. p. 7-29. [139 references]
Adaptation

Not applicable: The guideline was not adapted from another source.

Date Released
2009 Mar
Guideline Developer(s)
European Association of Urology - Medical Specialty Society
Source(s) of Funding

European Association of Urology

Guideline Committee

Renal Transplantation Guidelines Writing Panel

Composition of Group That Authored the Guideline

Primary Authors: T. Kälble; A. Alcaraz; K. Budde; U. Humke; G. Karam; M. Lucan; G. Nicita; C. Süsal

Financial Disclosures/Conflicts of Interest

All members of the Renal Transplantation Guidelines writing panel have provided disclosure statements on all relationships that they have and that might be perceived to be a potential source of conflict of interest. This information is kept on file in the European Association of Urology (EAU) Central Office database. This guidelines document was developed with the financial support of the EAU. No external sources of funding and support have been involved. The EAU is a non-profit organisation and funding is limited to administrative assistance and travel and meeting expenses. No honoraria or other reimbursements have been provided.

Guideline Status

This is the current release of the guideline.

Guideline Availability

Electronic copies: Available in Portable Document Format (PDF) from the European Association of Urology Web site External Web Site Policy.

Print copies: Available from the European Association of Urology, PO Box 30016, NL-6803, AA ARNHEM, The Netherlands.

Availability of Companion Documents

The following are available:

  • EAU guidelines office template. Arnhem, The Netherlands: European Association of Urology; 2007. 4 p.
  • The European Association of Urology (EAU) guidelines methodology: a critical evaluation. Arnhem, The Netherlands: European Association of Urology; 18 p.

The following is also available:

  • Guidelines on renal transplantation. 2009, Pocket guidelines. Arnhem, The Netherlands: European Association of Urology; 2009 Mar. 12 p. Electronic copies: Available in Portable Document Format (PDF) in English External Web Site Policy and Russian External Web Site Policy from the European Association of Urology Web site. Also available as an e-book from the EAU Web site External Web Site Policy.

Print copies: Available from the European Association of Urology, PO Box 30016, NL-6803, AA ARNHEM, The Netherlands.

Patient Resources

None available

NGC Status

This NGC summary was completed by ECRI Institute on April 16, 2010. The information was verified by the guideline developer on May 21, 2010.

Copyright Statement

This summary is based on the original guideline, which is subject to the guideline developer's copyright restrictions.

Downloads are restricted to one download and print per user, no commercial usage or dissemination by third parties is allowed.

Disclaimer

NGC Disclaimer

The National Guideline Clearinghouse™ (NGC) does not develop, produce, approve, or endorse the guidelines represented on this site.

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