Thyroid and Adrenocortical Hormone Replacement in Organ Donors

Sponsor

Medical University of South Carolina (Other)

Overall Status

Completed

CT.gov ID

NCT04528797

Collaborator

We Are Sharing Hope SC (Other)

199

Enrollment

Arms

36.9

Actual Duration (Months)

Study Details

Study Description

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:

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)
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)
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).

Condition or Disease	Intervention/Treatment	Phase
Brain Death	Drug: Levothyroxine Drug: Methylprednisolone	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

199 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Cadaveric Organ Donor Management: Thyroid and Adrenocortical Hormone Replacement

Actual Study Start Date :

Sep 2, 2010

Actual Primary Completion Date :

Aug 9, 2012

Actual Study Completion Date :

Sep 30, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: Levothyroxine
Experimental: 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.	Drug: Methylprednisolone
Experimental: Combination 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.	Drug: Levothyroxine Drug: Methylprednisolone
No Intervention: Control No levothyroxine or methylprednisolone administered.

Outcome Measures

Primary Outcome Measures

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

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