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Thyroid and Adrenocortical Hormone Replacement in Organ Donors

Primary Purpose

Brain Death

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Levothyroxine
Methylprednisolone
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain Death

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    No Intervention

    Arm Label

    Levothyroxine

    Methylprednisolone

    Combination

    Control

    Arm Description

    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.

    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.

    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.

    No levothyroxine or methylprednisolone administered.

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    Proportion of organs procured vs. consented, stratified by treatment group
    Recipient Morbidity
    Selected graft recipient morbidity measures in all organs transplanted stratified by treatment group
    Recipient Mortality
    Recipient death by 90 days post transplant

    Full Information

    First Posted
    August 20, 2020
    Last Updated
    August 24, 2020
    Sponsor
    Medical University of South Carolina
    Collaborators
    We Are Sharing Hope SC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04528797
    Brief Title
    Thyroid and Adrenocortical Hormone Replacement in Organ Donors
    Official Title
    Cadaveric Organ Donor Management: Thyroid and Adrenocortical Hormone Replacement
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2, 2010 (Actual)
    Primary Completion Date
    August 9, 2012 (Actual)
    Study Completion Date
    September 30, 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Medical University of South Carolina
    Collaborators
    We Are Sharing Hope SC

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. 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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Brain Death

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    199 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Levothyroxine
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Methylprednisolone
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Combination
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    No levothyroxine or methylprednisolone administered.
    Intervention Type
    Drug
    Intervention Name(s)
    Levothyroxine
    Intervention Type
    Drug
    Intervention Name(s)
    Methylprednisolone
    Primary Outcome Measure Information:
    Title
    Change in Vasoactive Inotrope Score (VIS) score from beginning of active donor management until procurement.
    Description
    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
    Secondary Outcome Measure Information:
    Title
    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
    Title
    Recipient Morbidity
    Description
    Selected graft recipient morbidity measures in all organs transplanted stratified by treatment group
    Time Frame
    90 days post transplant
    Title
    Recipient Mortality
    Description
    Recipient death by 90 days post transplant
    Time Frame
    90 days post traansplant

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    There is currently no plan in place to share IPD for this study
    Citations:
    PubMed Identifier
    35389961
    Citation
    Van Bakel AB, Hino SA, Welker D, Morella K, Gregoski MJ, Craig ML, Crumbley AJ, Sade RM. Hemodynamic Effects of High-dose Levothyroxine and Methylprednisolone in Brain-dead Potential Organ Donors. Transplantation. 2022 Aug 1;106(8):1677-1689. doi: 10.1097/TP.0000000000004072. Epub 2022 Jul 22.
    Results Reference
    derived

    Learn more about this trial

    Thyroid and Adrenocortical Hormone Replacement in Organ Donors

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