Thyroid and Adrenocortical Hormone Replacement in Organ Donors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

199 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-02

Study Completion Date

2013-09-30

Brief Summary

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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).

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Detailed Description

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Conditions

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Brain Death

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Levothyroxine

Intervention Type DRUG

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.

Group Type EXPERIMENTAL

Methylprednisolone

Intervention Type DRUG

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.

Group Type EXPERIMENTAL

Levothyroxine

Intervention Type DRUG

Methylprednisolone

Intervention Type DRUG

Control

No levothyroxine or methylprednisolone administered.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Levothyroxine

Intervention Type DRUG

Methylprednisolone

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No