Evaluation of the Efficacy and Safety of Levothyroxine in Brain Death Organ Donors: a Randomized Controled Trial

• Status: Terminated
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hopital du Sacre-Coeur de Montreal

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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)