An interventional study of Levothyroxine and Methylprednisolone in Brain Death, sponsored by Medical University of South Carolina. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-08-27.
Sponsored by Medical University of South Carolina · Not applicable, Interventional, and Treatment
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:
74 studies on the registry are indexed under Brain Death; 10 are open to participants now.
This study's enrollment of 199 is above the median of 154 across 39 interventional studies indexed under Brain Death.
Browse Brain Death studies →Medical University of South Carolina is the lead sponsor of 874 studies on the registry; 166 are open to participants now.
Of its 131 completed or terminated interventional studies of FDA-regulated products, 104 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
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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
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
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
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 levothyroxine or methylprednisolone administered.
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
Time frame: From baseline (t0) = beginning of active donor management to procurement (tOR) = time of organ procurement, up to 50 hours
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
Recipient Morbidity
Selected graft recipient morbidity measures in all organs transplanted stratified by treatment group
Time frame: 90 days post transplant
Recipient Mortality
Recipient death by 90 days post transplant
Time frame: 90 days post traansplant
No study locations are listed for this record.
Plan to share: No — There is currently no plan in place to share IPD for this study
Ran from Sep 2010 to primary completion in Aug 2012, 23 months.
Of 14 interventional studies with no phase under Brain Death, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 52. This study's 23 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Thyroxine · Methylprednisolone
Medical University of South Carolina →