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

Phase 4

Terminated

• Conditions: Brain Dead Organ Donors
• Interventions: Drug: Levothyroxine; Drug: placebo

• Registration Number: NCT02211053
• Lead Sponsor: Hopital du Sacre-Coeur de Montreal

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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-08-01
• Study First Submitted QC: 2014-08-05
• Study First Posted: 2014-08-07
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-13
• Last Update Posted: 2018-07-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 15

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Levothyroxine	Levothyroxine	Levothyroxine infusion 20 mg IV bolus then 10 mg/h infusion
Placebo	placebo	Infusion matched to intervention arm

Primary Outcome Measures

Name	Time	Method
Study feasibility	In 2 years	1) proportion of eligible recruited patients 2)proportion of recruited patients who completed the study 3) proportion of protocol violation
Variation in left ventricular ejection fraction	6 hours post infusion

Secondary Outcome Measures

Name	Time	Method
Numbers of donated hearts	On organ donation surgery
Incidence of de novo atrial fibrillation	From beginning of infusion until beginning of retrieval surgery
Time from recruitment to the administration of the study drug	From randomization to 12 hours post randomization

Trial Locations

Locations (1)

Hopital du Sacré-Coeur de Montreal; 🇨🇦 Montreal, Quebec, Canada