A multicenter randomized placebo-controlled trial of intravenous thyroxine for heart-eligible brain-dead organ donors

Abstract 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)...

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Autores principales:	Rajat Dhar, Dean Klinkenberg, Gary Marklin
Formato:	article
Lenguaje:	EN
Publicado:	BMC 2021
Materias:	Brain death Organ donation Heart transplant Thyroid hormone Donor management Medicine (General) R5-920
Acceso en línea:	https://doaj.org/article/bad7adb07bd244aab880336b40510960
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spelling	oai:doaj.org-article:bad7adb07bd244aab880336b405109602021-11-28T12:28:46ZA multicenter randomized placebo-controlled trial of intravenous thyroxine for heart-eligible brain-dead organ donors10.1186/s13063-021-05797-21745-6215https://doaj.org/article/bad7adb07bd244aab880336b405109602021-11-01T00:00:00Zhttps://doi.org/10.1186/s13063-021-05797-2https://doaj.org/toc/1745-6215Abstract 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 h or saline placebo. The primary study hypotheses are that thyroxine treatment will result in a higher proportion of hearts transplanted and that these hearts will have non-inferior function to hearts not treated with thyroxine. Additional outcome measures are the 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 in 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 intravenous thyroxine treatment increases hearts transplanted and/or provides hemodynamic benefits for donor management. Trial registration ClinicalTrials.gov NCT04415658 . Registered on June 4, 2020Rajat DharDean KlinkenbergGary MarklinBMCarticleBrain deathOrgan donationHeart transplantThyroid hormoneDonor managementMedicine (General)R5-920ENTrials, Vol 22, Iss 1, Pp 1-11 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Brain death Organ donation Heart transplant Thyroid hormone Donor management Medicine (General) R5-920
spellingShingle	Brain death Organ donation Heart transplant Thyroid hormone Donor management Medicine (General) R5-920 Rajat Dhar Dean Klinkenberg Gary Marklin A multicenter randomized placebo-controlled trial of intravenous thyroxine for heart-eligible brain-dead organ donors
description	Abstract 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 h or saline placebo. The primary study hypotheses are that thyroxine treatment will result in a higher proportion of hearts transplanted and that these hearts will have non-inferior function to hearts not treated with thyroxine. Additional outcome measures are the 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 in 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 intravenous thyroxine treatment increases hearts transplanted and/or provides hemodynamic benefits for donor management. Trial registration ClinicalTrials.gov NCT04415658 . Registered on June 4, 2020
format	article
author	Rajat Dhar Dean Klinkenberg Gary Marklin
author_facet	Rajat Dhar Dean Klinkenberg Gary Marklin
author_sort	Rajat Dhar
title	A multicenter randomized placebo-controlled trial of intravenous thyroxine for heart-eligible brain-dead organ donors
title_short	A multicenter randomized placebo-controlled trial of intravenous thyroxine for heart-eligible brain-dead organ donors
title_full	A multicenter randomized placebo-controlled trial of intravenous thyroxine for heart-eligible brain-dead organ donors
title_fullStr	A multicenter randomized placebo-controlled trial of intravenous thyroxine for heart-eligible brain-dead organ donors
title_full_unstemmed	A multicenter randomized placebo-controlled trial of intravenous thyroxine for heart-eligible brain-dead organ donors
title_sort	multicenter randomized placebo-controlled trial of intravenous thyroxine for heart-eligible brain-dead organ donors
publisher	BMC
publishDate	2021
url	https://doaj.org/article/bad7adb07bd244aab880336b40510960
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A multicenter randomized placebo-controlled trial of intravenous thyroxine for heart-eligible brain-dead organ donors

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