Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
University Hospital Mannheim Eurotransplant International Foundation, Leiden, The Netherlands Regional organ procurement organization (DSO), Baden-Wuerttemberg, Germany Regional Organ Procurement Organization (DSO), Bavaria, Germany Novartis |
---|---|
Information provided by: | University Hospital Mannheim |
ClinicalTrials.gov Identifier: | NCT00115115 |
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.
Condition | Intervention | Phase |
---|---|---|
Kidney Transplantation ESRD |
Drug: Dopamine infusion to brain dead organ donors |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Prospective Randomized Trial to Evaluate the Efficacy of Donor Preconditioning With Dopamine on Initial Graft Function After Kidney Transplantation |
Estimated Enrollment: | 302 |
Study Start Date: | March 2004 |
Estimated Study Completion Date: | March 2009 |
Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Donors:
Recipients:
Exclusion Criteria:
Donors:
Recipients:
Germany, Baden-Wuerttemberg | |
University Hospital Mannheim | |
Mannheim, Baden-Wuerttemberg, Germany, 68135 |
Principal Investigator: | Peter Schnuelle, MD | University Hospital Mannheim |
Study Chair: | Fokko J van der Woude, MD, PhD | University Hospital Mannheim |
Study Director: | Werner Lauchart, MD | Organ procurement organization (DSO) of Baden-Wuerttemberg |
Study Director: | Detlef Boesebeck, MD | Organ procurement organization (DSO) of Bavaria |
Responsible Party: | University Hospital Mannheim, Dept. of Medicine V, Theodor Kutzer Ufer 1-3, 68135 Mannheim, Germany ( Peter Schnuelle, MD ) |
Study ID Numbers: | 3074_KAC03.wpd |
Study First Received: | June 20, 2005 |
Last Updated: | November 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00115115 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Donor dopamine Immediate graft function Kidney transplantation |
Dopamine |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Autonomic Agents Sympathomimetics Cardiotonic Agents Therapeutic Uses |
Physiological Effects of Drugs Dopamine Agents Peripheral Nervous System Agents Cardiovascular Agents Protective Agents Pharmacologic Actions |