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Kidney TransplantationPhase 4NCT00115115

Donor Dopamine and Initial Graft Function

A Phase 4 study testing Dopamine infusion to brain dead organ donors in people with Kidney Transplantation and ESRD, run by Universitätsmedizin Mannheim at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Kidney Transplantation, ESRD
What is being tested?
Dopamine infusion to brain dead organ donors
Type of treatment
Injection or infusion
How many people
487 participants
Where
1 siteGermany
Study dates
Mar 2004to Mar 2009
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Donors:
  • Brain death confirmed
  • Given consent to organ donation
  • Current s-creatinine < 2mg/dl
  • On admission s-creatinine < 1.3mg/dl
  • Recipients:
Show all 9Show fewer
  • Age over 18 years
  • Placed on the waiting list
  • Organ allocation according to ET standards

Who cannot join

  • Donors:
  • Application of dopamine/dobutamine/adrenaline
  • Application of noradrenaline > 0.4µg/kg*min
  • Hemodynamic instability
  • Recipients:
  • Refusal to participate in study /data analysis
  • Pregnancy

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • University Hospital Mannheim

    Mannheim, Baden-Wurttemberg, 68135

Other trials in Germany

About this study

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.

Read the 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.

Being tested
Dopamine infusion to brain dead organ donors
Keywords
Donor dopamine, Immediate graft function, Kidney transplantation
Medical subject headings
Kidney Failure, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dopamine infusion to brain dead organ donorsDrug

    Dopamine infusion administered at a dosage of 4µg/kg/min starting after brain death has been proven until to surgical procurement of the kidneys

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Requirement of hemodialysis post-transplant

    Measured: within 1 week after surgery

Secondary outcomes (3)

  1. Incidence and severity of acute rejection episodes

    Measured: within the first 30 days (plus minus 3 days) after surgery

  2. S-creatinine on days 1-7 post transplant

    Measured: within the first week after transplantation

  3. Patient and graft survival

    Measured: after 12, 24 and 36 months post-transplant

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jun 2005 (estimated)
  2. Study startMar 2004
  3. Primary completionDec 2007
  4. Study completionMar 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
487 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00115115
Sponsor's protocol ID
3074_KAC03.wpd
Status last verified
Apr 2009
First submitted
20 Jun 2005
Last updated
23 Apr 2009
Results posted
No
Data monitoring committee
No

Publications

  • 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. doi: 10.1111/j.1600-6143.2004.00331.x.

    PubMed 14961996

  • Yard B, Beck G, Schnuelle P, Braun C, Schaub M, Bechtler M, Gottmann U, Xiao Y, Breedijk A, Wandschneider S, Losel 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. doi: 10.1046/j.1600-6143.2003.00268.x.

    PubMed 14678031

  • 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. doi: 10.1097/00007890-200108150-00017.

    PubMed 11502976

  • 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. doi: 10.1046/j.1523-1755.1999.00567.x.

    PubMed 10432416

  • Benck U, Jung M, Kruger B, Grimm A, Weiss C, Yard BA, Lehner F, Kiessling A, Fischer L, Gallinat A, Kleespies A, Lorf T, Sucher R, Monch C, Scherer MN, Rahmel A, Schemmer P, Kramer BK, Schnuelle P. Donor Dopamine Does Not Affect Liver Graft Survival: Evidence of Safety From a Randomized Controlled Trial. Liver Transpl. 2018 Oct;24(10):1336-1345. doi: 10.1002/lt.25301.

    PubMed 30102825

  • Schnuelle P, Benck U, Kramer BK, Yard BA, Zuckermann A, Wagner F, Szabo G, Borggrefe M, Karck M, Gummert J. Impact of Donor Core Body Temperature on Graft Survival After Heart Transplantation. Transplantation. 2018 Nov;102(11):1891-1900. doi: 10.1097/TP.0000000000002337.

    PubMed 29994980

  • Schnuelle P, Mundt HM, Druschler F, Schmitt WH, Yard BA, Kramer BK, Benck U. Impact of spontaneous donor hypothermia on graft outcomes after kidney transplantation. Am J Transplant. 2018 Mar;18(3):704-714. doi: 10.1111/ajt.14541. Epub 2017 Nov 22.

    PubMed 29027352

  • Schnuelle P, Schmitt WH, Weiss C, Habicht A, Renders L, Zeier M, Druschler F, Heller K, Pisarski P, Banas B, Kramer BK, Jung M, Lopau K, Olbricht CJ, Weihprecht H, Schenker P, De Fijter JW, Yard BA, Benck U. Effects of Dopamine Donor Pretreatment on Graft Survival after Kidney Transplantation: A Randomized Trial. Clin J Am Soc Nephrol. 2017 Mar 7;12(3):493-501. doi: 10.2215/CJN.07600716. Epub 2017 Feb 17.

    PubMed 28213388

  • Benck U, Gottmann U, Hoeger S, Lammert A, Rose D, Boesebeck D, Lauchart W, Birck R, Weiss C, Kramer BK, Yard BA, Schnuelle P. Donor desmopressin is associated with superior graft survival after kidney transplantation. Transplantation. 2011 Dec 15;92(11):1252-8. doi: 10.1097/TP.0b013e318236cd4c.

    PubMed 22067309

  • Benck U, Hoeger S, Brinkkoetter PT, Gottmann U, Doenmez D, Boesebeck D, Lauchart W, Gummert J, Karck M, Lehmkuhl HB, Bittner HB, Zuckermann A, Wagner F, Schulz U, Koch A, Bigdeli AK, Bara C, Hirt S, Berchtold-Herz M, Brose S, Herold U, Boehm J, Welp H, Strecker T, Doesch A, Birck R, Kramer BK, Yard BA, Schnuelle P. Effects of donor pre-treatment with dopamine on survival after heart transplantation: a cohort study of heart transplant recipients nested in a randomized controlled multicenter trial. J Am Coll Cardiol. 2011 Oct 18;58(17):1768-77. doi: 10.1016/j.jacc.2011.05.060.

    PubMed 21996389

  • Schnuelle P, Gottmann U, Hoeger S, Boesebeck D, Lauchart W, Weiss C, Fischereder M, Jauch KW, Heemann U, Zeier M, Hugo C, Pisarski P, Kramer BK, Lopau K, Rahmel A, Benck U, Birck R, Yard BA. Effects of donor pretreatment with dopamine on graft function after kidney transplantation: a randomized controlled trial. JAMA. 2009 Sep 9;302(10):1067-75. doi: 10.1001/jama.2009.1310.

    PubMed 19738091

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Dopamine infusion to brain dead organ donors in people with Kidney Transplantation and ESRD, run by Universitätsmedizin Mannheim at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Requirement of hemodialysis post-transplant (time frame: within 1 week after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00115115, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2009.

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