Intravenous Thyroxine for Heart-Eligible Organ Donors

  • STATUS
    Recruiting
  • days left to enroll
    27
  • participants needed
    800
  • sponsor
    Washington University School of Medicine
Updated on 8 December 2021
inotropic agent

Summary

This randomized controlled trial will evaluate whether intravenous thyroxine infusion given to brain-dead organ donors who are eligible to donate hearts for 12 hours will result in more hearts transplanted than saline placebo

Description

Background: Brain death frequently induces hemodynamic instability and cardiac stunning. Impairments in cardiac performance are major contributors to hearts from otherwise eligible organ donors not being transplanted. Deficiencies in pituitary hormones (including thyroid stimulating hormone) may contribute to hemodynamic instability and replacement of thyroid hormone has been proposed as a means of improving stability and increasing hearts available for transplantation. Intravenous thyroxine is commonly used in donor management. However, small controlled trials have not been able to demonstrate efficacy.

Methods: This multicenter study will involve organ procurement organizations (OPOs) across the country. A total of 800 heart-eligible brain dead organ donors who require vasopressor support will be randomly assigned to intravenous thyroxine for at least 12-hours or saline placebo. The primary study hypothesis is that thyroxine treatment results in more hearts transplanted. Additional outcome measures are time to achieve hemodynamic stability (weaning off vasopressors) and improvement in cardiac ejection fraction on echocardiography.

Discussion: This will be the largest randomized controlled study to evaluate the efficacy of thyroid hormone treatment for organ donor management. By collaborating across multiple OPOs, it will be able to enroll an adequate number of donors and be powered to definitively answer the critical question of whether treatment increases hearts transplanted and/or provides other hemodynamic benefits.

Details
Condition congestive heart disease, Congestive Heart Failure, cardiac failure, Heart Failure, Cardiac Disease, Brain Death, Heart disease, Heart failure, Heart Disease
Treatment Saline, Thyroxine
Clinical Study IdentifierNCT04415658
SponsorWashington University School of Medicine
Last Modified on8 December 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Declared dead by neurologic criteria (brain dead)
Authorization for organ donation and research
On one or more vasopressors and/or inotropes

Exclusion Criteria

Brain death declared more than 24 hours prior
Only vasopressor is vasopressin
Known coronary artery disease or history of myocardial infarction
Weight < 45 kg (100 lbs)
Known valvular heart disease
Prior sternotomy or cardiac surgery
Donor at VA hospital
Received intravenous or oral thyroxine within past month
Other reason donor is unable to receive study drug (determined by on-site personnel)
Known HIV+ status
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