Kidney Transplantation Clinical Trial
Official title:
Prospective Randomized Trial to Evaluate the Efficacy of Donor Preconditioning With Dopamine on Initial Graft Function After Kidney Transplantation
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.
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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