Brain Death
Conditions
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).
Interventions
DRUGLevothyroxine
DRUGMethylprednisolone
Sponsors
We Are Sharing Hope SC
Medical University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Vasoactive Inotrope Score (VIS) score from beginning of active donor management until procurement. | 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
| Measure | Time frame | Description |
|---|---|---|
| Proportion of organs procured vs. consented, stratified by treatment group | assessed at time of procurement, up to 50 hours following consent for donation | — |
| Recipient Morbidity | 90 days post transplant | Selected graft recipient morbidity measures in all organs transplanted stratified by treatment group |
| Recipient Mortality | 90 days post traansplant | Recipient death by 90 days post transplant |
Outcome results
None listed