Thyroid and Adrenocortical Hormone Replacement in Organ Donors

Brain Death Clinical Trial

Official title:

Cadaveric Organ Donor Management: Thyroid and Adrenocortical Hormone Replacement

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04528797
• Other study ID #: HR 17718
• Status: Completed
• Phase: N/A
• Start date: September 2, 2010
• Est. completion date: September 30, 2013

Study information

• Verified date: August 2020
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 199
• Est. completion date: September 30, 2013
• Est. primary completion date: August 9, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Death

Intervention

Drug:
• Levothyroxine

• Methylprednisolone

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of South Carolina	We Are Sharing Hope SC

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	From baseline (t0) = beginning of active donor management to procurement (tOR) = time of organ procurement, up to 50 hours
Secondary	Proportion of organs procured vs. consented, stratified by treatment group		assessed at time of procurement, up to 50 hours following consent for donation
Secondary	Recipient Morbidity	Selected graft recipient morbidity measures in all organs transplanted stratified by treatment group	90 days post transplant
Secondary	Recipient Mortality	Recipient death by 90 days post transplant	90 days post traansplant