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Completed

NCT Number: NCT00115115

Donor Dopamine and Initial Graft Function

Donor pre-treatment with dopamine reduces injury to the kidney graft with consequences on the clinical performance immediately after transplantation: Donor dopamine reduces the requirement of dialysis post transplant, and results in renal function improvements.

The purpose of the study is to investigate the potentially therapeutic impact of donor preconditioning with low dose dopamine in human renal transplant recipients from a brain dead donor.

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Key information

About this study

During the transplantation process, the kidney graft is exposed to numerous events which may in turn lead to function deteriorations. In particular, factors related with brain death, like hemodynamic instability and systemic release of cytokines, cold preservation upon harvesting, and reperfusion injury accumulate in harm conveying a pro-inflammatory state to the graft before transplantation. Early graft dysfunction has long-term consequences. Renal transplants with delayed graft function and acute rejection have a greater incidence of chronic dysfunction. Allorecognition is induced when the host immune system detects alloantigens in the context of danger signals. Reducing danger signals through medical donor management may therefore have a considerable impact on the transplantation outcomes.

In a case control study from the Transplantation Center of Mannheim, Germany, donor use of both dopamine and noradrenaline during intensive care before organ retrieval was associated with less acute rejection episodes after transplantation and resulted in superior long-term graft survival. Donor employment of catecholamines remained predictive of an improved graft survival probability even after controlling for various confounding factors like age, gender, cold ischemia, HLA matching and immunosuppressive medication. This observation has been confirmed by a larger retrospective cohort study based on the Eurotransplant registry, including 2404 kidney transplants performed at 47 renal transplantation centers in 1993. The salutary effect on the graft function rate at 4 years exhibited a dose-response relationship and compared in quantitative terms with prospective HLA matching on class I or II antigens. Besides these long-term benefits, donor preconditioning with dopamine is associated with improvements of immediate graft function after kidney transplantation. Donor dopamine was associated with less requirement of hemodialysis and more rapid recovery of graft function posttransplant in a single centre study involving 254 consecutive renal transplant recipients.

Implementing dopamine as a therapeutic tool in the management of cadaver kidney donors may have a major impact on both immediate graft function and long-term graft survival without adverse side effects for the recipients.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Donors:

  • Brain death confirmed
  • Given consent to organ donation
  • Current s-creatinine < 2mg/dl
  • On admission s-creatinine < 1.3mg/dl

Recipients:

  • Age over 18 years
  • Placed on the waiting list
  • Organ allocation according to ET standards

Exclusion criteria

Donors:

  • Application of dopamine/dobutamine/adrenaline
  • Application of noradrenaline > 0.4µg/kg*min
  • Hemodynamic instability

Recipients:

  • Refusal to participate in study /data analysis
  • Pregnancy

Treatment and study plan

Dopamine infusion to brain dead organ donors

Drug

Dopamine infusion administered at a dosage of 4µg/kg/min starting after brain death has been proven until to surgical procurement of the kidneys

Primary outcomes

  1. Requirement of hemodialysis post-transplant

    Time frame: within 1 week after surgery

Secondary outcomes

  1. Incidence and severity of acute rejection episodes

    Time frame: within the first 30 days (plus minus 3 days) after surgery

  2. S-creatinine on days 1-7 post transplant

    Time frame: within the first week after transplantation

  3. Patient and graft survival

    Time frame: after 12, 24 and 36 months post-transplant

Sponsors and collaborators

Lead sponsor

Universitätsmedizin Mannheim

Other

Collaborators

  • Eurotransplant International Foundation, Leiden, The Netherlands
  • Novartis
  • Regional Organ Procurement Organization (DSO), Baden-Wuerttemberg, Germany
  • Regional Organ Procurement Organization (DSO), Bavaria, Germany

Registry information

Official study title

Prospective Randomized Trial to Evaluate the Efficacy of Donor Preconditioning With Dopamine on Initial Graft Function After Kidney Transplantation

Important dates

Study start
2004
Primary completion
2007
Study completion
2009
First posted
Jun 21, 2005
Registry last updated
Apr 23, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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