Status:
TERMINATED
Evaluation of the Efficacy and Safety of Levothyroxine in Brain Death Organ Donors: a Randomized Controled Trial
Lead Sponsor:
Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
Conditions:
Brain Dead Organ Donors
Eligibility:
All Genders
16+ years
Phase:
PHASE4
Brief Summary
The primary objective of this study is to evaluate the feasibility of a randomized controlled trial comparing levothyroxine to placebo in neurologically deceased donors
Eligibility Criteria
Inclusion
- Prior signed written informed from family member (no more needed following amendment in July 2016)
- 16 years of age or older
- Brain death diagnosis
- Left ventricular ejection fraction \< 50% determined by transthoracic echocardiography or hemodynamic instability defined as a mean dose of noradrenaline 0.1 mcg/kg/min + vasopressin
Exclusion
- Heart failure history (removed after june 2015)
- Chronic exogenous oral T4 or T3 before death (removed after june 2015)
- Having received T4 infusion before recruitment(removed after june 2015)
- Echographic images not interpretable
- Age 75 and older(removed after june 2015)
- Prior coronary heart disease defined as prior coronary artery bypass graft or percutaneous coronary intervention (with or without stents)(removed after june 2015)
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT02211053
Start Date
July 1 2014
End Date
December 1 2016
Last Update
July 17 2018
Active Locations (1)
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1
Hopital du Sacré-Coeur de Montreal
Montreal, Quebec, Canada, H4J1C5