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.
Status | Completed |
Enrollment | 487 |
Est. completion date | March 2009 |
Est. primary completion date | December 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Germany | University Hospital Mannheim | Mannheim | Baden-Wuerttemberg |
Lead Sponsor | Collaborator |
---|---|
Universitätsmedizin Mannheim | Eurotransplant International Foundation, Leiden, The Netherlands, Novartis, Regional Organ Procurement Organization (DSO), Baden-Wuerttemberg, Germany, Regional Organ Procurement Organization (DSO), Bavaria, Germany |
Germany,
Schnuelle P, Berger S, de Boer J, Persijn G, van der Woude FJ. Effects of catecholamine application to brain-dead donors on graft survival in solid organ transplantation. Transplantation. 2001 Aug 15;72(3):455-63. — View Citation
Schnuelle P, Lorenz D, Mueller A, Trede M, Van Der Woude FJ. Donor catecholamine use reduces acute allograft rejection and improves graft survival after cadaveric renal transplantation. Kidney Int. 1999 Aug;56(2):738-46. — View Citation
Schnuelle P, Yard BA, Braun C, Dominguez-Fernandez E, Schaub M, Birck R, Sturm J, Post S, van der Woude FJ. Impact of donor dopamine on immediate graft function after kidney transplantation. Am J Transplant. 2004 Mar;4(3):419-26. — View Citation
Yard B, Beck G, Schnuelle P, Braun C, Schaub M, Bechtler M, Göttmann U, Xiao Y, Breedijk A, Wandschneider S, Lösel R, Sponer G, Wehling M, van der Woude FJ. Prevention of cold-preservation injury of cultured endothelial cells by catecholamines and related compounds. Am J Transplant. 2004 Jan;4(1):22-30. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Requirement of hemodialysis post-transplant | within 1 week after surgery | No | |
Secondary | Incidence and severity of acute rejection episodes | within the first 30 days (plus minus 3 days) after surgery | No | |
Secondary | S-creatinine on days 1-7 post transplant | within the first week after transplantation | No | |
Secondary | Patient and graft survival | after 12, 24 and 36 months post-transplant | No |
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