Ignite Creation Date:
2024-05-06 @ 3:07 PM
Last Modification Date:
2024-10-26 @ 1:43 PM
Study NCT ID:
NCT04528797
Status:
COMPLETED
Last Update Posted:
2020-08-27
First Post:
2020-08-20
Brief Title:
Thyroid and Adrenocortical Hormone Replacement in Organ Donors
Sponsor:
Medical University of South Carolina
Organization:
Medical University of South Carolina
Study Overview
Official Title:
Cadaveric Organ Donor Management Thyroid and Adrenocortical Hormone Replacement
Status:
COMPLETED
Status Verified Date:
2020-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None