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Calcineurin Inhibitor in NEuRoloGically deceased donors to decrease kidney delayed graft function study: study

Frederick D'Aragon1,2, Markus Selzner3,4, Ruth Breau5

  • 1Department of Anesthesiology, Université de Sherbrooke, Sherbrooke, Quebec, Canada frederick.daragon@usherbrooke.ca.

BMJ Open
|June 13, 2024
PubMed
Summary
This summary is machine-generated.

This pilot trial investigates if donor preconditioning with calcineurin inhibitors, like tacrolimus, can improve organ transplant outcomes. The study assesses the feasibility of using this method to reduce ischemia reperfusion injury in recipients.

Keywords:
adult intensive & critical carefeasibility studiesrandomized controlled trialtransplant medicine

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Area of Science:

  • Transplantation immunology
  • Clinical trials
  • Organ donation

Background:

  • Solid organ transplants often use donors meeting neurological criteria for death (DNC).
  • Physiological changes post-brain death increase risks of ischemia reperfusion injury and delayed graft function.
  • Donor preconditioning with calcineurin inhibitors may mitigate these risks.

Purpose of the Study:

  • To assess the feasibility of a multicenter, placebo-controlled pilot randomized trial of donor preconditioning with tacrolimus.
  • To evaluate the impact of donor preconditioning on organ transplant outcomes, specifically graft function and survival.
  • To identify barriers in implementing such a trial in organ donation settings.

Main Methods:

  • A pilot randomized trial involving DNC donors and their organ recipients across Canadian provinces.
  • Donors received either tacrolimus or placebo intravenously before organ retrieval.
  • Graft function and survival were monitored in recipients; trial feasibility was assessed by enrollment and consent rates.

Main Results:

  • Feasibility outcomes, including donor enrollment and recipient consent rates, will be reported as proportions with 95% confidence intervals.
  • Hemodynamic changes during donor infusion were monitored.
  • Barriers to trial implementation were documented.

Conclusions:

  • The study aims to provide feasibility data for a larger trial on donor preconditioning in organ transplantation.
  • Results will inform future strategies to improve outcomes for DNC organ donors and recipients.
  • Successful implementation of donor preconditioning could enhance graft survival and reduce complications.