Donor Dopamine and Initial Graft Function

April 22, 2009 updated by: Universitätsmedizin Mannheim

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

487

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Baden-Wuerttemberg
      • Mannheim, Baden-Wuerttemberg, Germany, 68135
        • University Hospital Mannheim

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Requirement of hemodialysis post-transplant
Time Frame: within 1 week after surgery
within 1 week after surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence and severity of acute rejection episodes
Time Frame: within the first 30 days (plus minus 3 days) after surgery
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
within the first week after transplantation
Patient and graft survival
Time Frame: after 12, 24 and 36 months post-transplant
after 12, 24 and 36 months post-transplant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitätsmedizin Mannheim

Collaborators

Novartis
Eurotransplant International Foundation, Leiden, The Netherlands
Regional Organ Procurement Organization (DSO), Baden-Wuerttemberg, Germany
Regional Organ Procurement Organization (DSO), Bavaria, Germany

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2004

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

June 20, 2005

First Submitted That Met QC Criteria

June 20, 2005

First Posted (Estimate)

June 21, 2005

Study Record Updates

Last Update Posted (Estimate)

April 23, 2009

Last Update Submitted That Met QC Criteria

April 22, 2009

Last Verified

April 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3074_KAC03.wpd

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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