Thyroid and Adrenocortical Hormone Replacement in Organ Donors

Not Applicable

Completed

• Conditions: Brain Death
• Interventions: Drug: Levothyroxine; Drug: Methylprednisolone

• Registration Number: NCT04528797
• Lead Sponsor: Medical University of South Carolina

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09-02
• Primary Completion: 2012-08-09
• Study Completion: 2013-09-30
• Status Verified: 2020-08
• Study First Submitted: 2020-08-20
• Study First Submitted QC: 2020-08-24
• Last Update Submitted: 2020-08-24
• Study First Posted: 2020-08-27
• Last Update Posted: 2020-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 199

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

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Exclusion Criteria

Cadavers failing to meet inclusion criteria

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Combination	Levothyroxine	Methylprednsiolone 30 mg/kg (up to 2 g) IV initiated at the beginning of active donor management followed by repeat dosing of 15 mg/kg (up to 1 g) 12 hours later plus levothyroxine 20 mcg IV bolus initiated at the beginning of active donor management followed by continuous infusion of 50 to 200 mcg/hr titrated to minimize vasopressor requirements until organ procurement.
Methylprednisolone	Methylprednisolone	Methylprednsiolone 30 mg/kg (up to 2 g) IV initiated at the beginning of active donor management followed by repeat dosing of 15 mg/kg (up to 1 g) 12 hours later.
Levothyroxine	Levothyroxine	Levothyroxine 20 mcg IV bolus initiated at the beginning of active donor management followed by continuous infusion of 50 to 200 mcg/hr titrated to minimize vasopressor requirements until organ procurement.
Combination	Methylprednisolone	Methylprednsiolone 30 mg/kg (up to 2 g) IV initiated at the beginning of active donor management followed by repeat dosing of 15 mg/kg (up to 1 g) 12 hours later plus levothyroxine 20 mcg IV bolus initiated at the beginning of active donor management followed by continuous infusion of 50 to 200 mcg/hr titrated to minimize vasopressor requirements until organ procurement.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Recipient Morbidity	90 days post transplant	Selected graft recipient morbidity measures in all organs transplanted stratified by treatment group
Proportion of organs procured vs. consented, stratified by treatment group	assessed at time of procurement, up to 50 hours following consent for donation
Recipient Mortality	90 days post traansplant	Recipient death by 90 days post transplant