Evaluation of the Efficacy and Safety of Levothyroxine in Brain Death Organ Donors: a Randomized Controled Trial (ECHOT4)

July 13, 2018 updated by: Anne Julie Frenette, Hopital du Sacre-Coeur de Montreal

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

The primary objective of this study is to evaluate the feasibility of a randomized controlled trial comparing levothyroxine to placebo in neurologically deceased donors

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H4J1C5
        • Hôpital du Sacré-Cœur de Montréal

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Levothyroxine
Levothyroxine infusion 20 mg IV bolus then 10 mg/h infusion
Drug: Levothyroxine
20 mg IV bolus + 10 mg/h infusion
Other Names:
  • Synthroid(R)
Placebo Comparator: Placebo
Infusion matched to intervention arm
Drug: placebo

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hopital du Sacre-Coeur de Montreal

Investigators

  • Principal Investigator: Anne Julie Frenette, M.Sc, Hôpital du Sacré-Cœur de Montréal

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2014

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

August 1, 2014

First Submitted That Met QC Criteria

August 5, 2014

First Posted (Estimate)

August 7, 2014

Study Record Updates

Last Update Posted (Actual)

July 17, 2018

Last Update Submitted That Met QC Criteria

July 13, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-987

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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