Overview

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)