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

Brain Dead Organ Donors Clinical Trial

— ECHOT4  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02211053
• Other study ID #: 2014-987
• Status: Terminated
• Phase: Phase 4
• Start date: July 2014
• Est. completion date: December 2016

Study information

• Verified date: July 2018
• Source: Hopital du Sacre-Coeur de Montreal
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Brain Dead Organ Donors
• Brain Death

Intervention

Drug:
• Levothyroxine
20 mg IV bolus + 10 mg/h infusion
• placebo

Locations

Country	Name	City	State
Canada	Hopital du Sacré-Coeur de Montreal	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Hopital du Sacre-Coeur de Montreal

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Study feasibility	1) proportion of eligible recruited patients 2)proportion of recruited patients who completed the study 3) proportion of protocol violation	In 2 years
Primary	Variation in left ventricular ejection fraction		6 hours post infusion
Secondary	Numbers of donated hearts		On organ donation surgery
Secondary	Incidence of de novo atrial fibrillation		From beginning of infusion until beginning of retrieval surgery
Secondary	Time from recruitment to the administration of the study drug		From randomization to 12 hours post randomization