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OpenTrials
Completed

NCT Number: NCT04528797

Thyroid and Adrenocortical Hormone Replacement in Organ Donors

Brain death inevitably leads to hemodynamic instability and prolonged hypotension that compromises viability of potentially transplantable organs. In addition to depletion of peripheral norepinephrine stores, concomitant depletion of thyroid hormone and cortisol levels are believed to contribute to this instability. Catecholamine vasopressors are widely used to support hemodynamics in potential organ donors, however their use has also been shown to compromise allograft function.

Trials studying the effects of thyroid hormone and corticosteroid treatment on brain dead organ donors have had mixed results with respect to improving donor hemodynamics. Further, few studies have attempted to discriminate the relative contribution of thyroid hormone vs. corticosteroids.

The specific aims of this study include:

1. To quantify hemodynamic changes during the management of cadaveric organ donors routinely receiving thyroid hormone therapy alone vs. corticosteroid therapy alone vs. the combination, compared to those who do not receive any hormonal therapy (controls) 2. To document number and types of organs procured in donors treated with thyroid hormone therapy alone vs. corticosteroid therapy alone vs. the combination, compared to those not treated with hormonal therapy (controls) 3. To quantify graft and patient outcomes in recipients of organs exposed to thyroid hormone therapy alone vs. corticosteroid therapy alone vs. the combination, compared to recipients of organs not exposed to hormonal therapy (controls).

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Cadaveric organ donors ≥ age 18 having valid consent (by advance directive or by familial consent) to donate organs.

Recipients of these cadaveric organs

Exclusion criteria

Cadavers failing to meet inclusion criteria

Treatment and study plan

Levothyroxine

Drug

methylprednisolone

Drug

Primary outcomes

  1. Change in Vasoactive Inotrope Score (VIS) score from beginning of active donor management until procurement.

    Time frame: From baseline (t0) = beginning of active donor management to procurement (tOR) = time of organ procurement, up to 50 hours

    The VIS score includes all commonly used vasopressor and inotrope agents, weighted by potency and summed

Secondary outcomes

  1. Proportion of organs procured vs. consented, stratified by treatment group

    Time frame: assessed at time of procurement, up to 50 hours following consent for donation

  2. Recipient Morbidity

    Time frame: 90 days post transplant

    Selected graft recipient morbidity measures in all organs transplanted stratified by treatment group

  3. Recipient Mortality

    Time frame: 90 days post traansplant

    Recipient death by 90 days post transplant

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Collaborators

  • We Are Sharing Hope SC

Registry information

Official study title

Cadaveric Organ Donor Management: Thyroid and Adrenocortical Hormone Replacement

Important dates

Study start
2010
Primary completion
2012
Study completion
2013
First posted
Aug 27, 2020
Registry last updated
Aug 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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