Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00115115
Status:
COMPLETED
Last Update Posted:
2009-04-23
First Post:
2005-06-20
Brief Title:
Donor Dopamine and Initial Graft Function
Sponsor:
Universitätsmedizin Mannheim
Organization:
Universitätsmedizin Mannheim
Study Overview
Official Title:
Prospective Randomized Trial to Evaluate the Efficacy of Donor Preconditioning With Dopamine on Initial Graft Function After Kidney Transplantation
Status:
COMPLETED
Status Verified Date:
2009-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None