Clinical trial NCT04528797: Thyroid and Adrenocortical Hormone Replacement in Organ Donors
Official title: Cadaveric Organ Donor Management: Thyroid and Adrenocortical Hormone Replacement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Death
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: We Are Sharing Hope SC
First posted: 2020-08-27
Enrollment: 199
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility criteria: 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

Primary outcomes:
measure: Change in Vasoactive Inotrope Score (VIS) score from beginning of active donor management until procurement.
timeFrame: From baseline (t0) = beginning of active donor management to procurement (tOR) = time of organ procurement, up to 50 hours
Secondary outcomes:
measure: Proportion of organs procured vs. consented, stratified by treatment group
timeFrame: assessed at time of procurement, up to 50 hours following consent for donation
measure: Recipient Morbidity
timeFrame: 90 days post transplant
measure: Recipient Mortality
timeFrame: 90 days post traansplant
Other outcomes:
Locations:
Study officials:
References:
citation: Van Bakel AB, Hino SA, Welker D, Morella K, Gregoski MJ, Craig ML, Crumbley AJ, Sade RM. Hemodynamic Effects of High-dose Levothyroxine and Methylprednisolone in Brain-dead Potential Organ Donors. Transplantation. 2022 Aug 1;106(8):1677-1689. doi: 10.1097/TP.0000000000004072. Epub 2022 Jul 22.