Donor Dopamine and Initial Graft Function
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|ClinicalTrials.gov Identifier: NCT00115115|
Recruitment Status : Completed
First Posted : June 21, 2005
Last Update Posted : April 23, 2009
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 or disease||Intervention/treatment||Phase|
|Kidney Transplantation ESRD||Drug: Dopamine infusion to brain dead organ donors||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||487 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prospective Randomized Trial to Evaluate the Efficacy of Donor Preconditioning With Dopamine on Initial Graft Function After Kidney Transplantation|
|Study Start Date :||March 2004|
|Actual Primary Completion Date :||December 2007|
|Actual Study Completion Date :||March 2009|
- Drug: Dopamine infusion to brain dead organ donors
Dopamine infusion administered at a dosage of 4µg/kg/min starting after brain death has been proven until to surgical procurement of the kidneys
- Requirement of hemodialysis post-transplant [ Time Frame: within 1 week after surgery ]
- Incidence and severity of acute rejection episodes [ Time Frame: within the first 30 days (plus minus 3 days) after surgery ]
- S-creatinine on days 1-7 post transplant [ Time Frame: within the first week after transplantation ]
- Patient and graft survival [ Time Frame: after 12, 24 and 36 months post-transplant ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00115115
|University Hospital Mannheim|
|Mannheim, Baden-Wuerttemberg, Germany, 68135|
|Principal Investigator:||Peter Schnuelle, MD||Universitätsmedizin Mannheim|
|Study Chair:||Fokko J van der Woude, MD, PhD||Universitätsmedizin Mannheim|
|Study Director:||Werner Lauchart, MD||Organ procurement organization (DSO) of Baden-Wuerttemberg|
|Study Director:||Detlef Boesebeck, MD||Organ procurement organization (DSO) of Bavaria|