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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
199
Change in Vasoactive Inotrope Score (VIS) score from beginning of active donor management until procurement.
The VIS score includes all commonly used vasopressor and inotrope agents, weighted by potency and summed
Time frame: From baseline (t0) = beginning of active donor management to procurement (tOR) = time of organ procurement, up to 50 hours
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
Recipient Morbidity
Selected graft recipient morbidity measures in all organs transplanted stratified by treatment group
Time frame: 90 days post transplant
Recipient Mortality
Recipient death by 90 days post transplant
Time frame: 90 days post traansplant
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