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

Primary Purpose

Brain Dead Organ Donors

Status
Terminated
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Levothyroxine
placebo
Sponsored by
Hopital du Sacre-Coeur de Montreal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Brain Dead Organ Donors focused on measuring Organ donation, Brain dead, Levothyroxine

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Hopital du Sacré-Coeur de Montreal

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Levothyroxine

Placebo

Arm Description

Levothyroxine infusion 20 mg IV bolus then 10 mg/h infusion

Infusion matched to intervention arm

Outcomes

Primary Outcome Measures

Study feasibility
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

Secondary Outcome Measures

Numbers of donated hearts
Incidence of de novo atrial fibrillation
Time from recruitment to the administration of the study drug

Full Information

First Posted
August 1, 2014
Last Updated
July 13, 2018
Sponsor
Hopital du Sacre-Coeur de Montreal
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1. Study Identification

Unique Protocol Identification Number
NCT02211053
Brief Title
Evaluation of the Efficacy and Safety of Levothyroxine in Brain Death Organ Donors: a Randomized Controled Trial
Acronym
ECHOT4
Official Title
Evaluation of the Efficacy and Safety of Levothyroxine in Brain Death Organ Donors: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Terminated
Why Stopped
Recruitment was too slow and we cannot anticipate to recruit the target sample size
Study Start Date
July 2014 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hopital du Sacre-Coeur de Montreal

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Dead Organ Donors
Keywords
Organ donation, Brain dead, Levothyroxine

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Levothyroxine
Arm Type
Active Comparator
Arm Description
Levothyroxine infusion 20 mg IV bolus then 10 mg/h infusion
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Infusion matched to intervention arm
Intervention Type
Drug
Intervention Name(s)
Levothyroxine
Other Intervention Name(s)
Synthroid(R)
Intervention Description
20 mg IV bolus + 10 mg/h infusion
Intervention Type
Drug
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
Study feasibility
Description
1) proportion of eligible recruited patients 2)proportion of recruited patients who completed the study 3) proportion of protocol violation
Time Frame
In 2 years
Title
Variation in left ventricular ejection fraction
Time Frame
6 hours post infusion
Secondary Outcome Measure Information:
Title
Numbers of donated hearts
Time Frame
On organ donation surgery
Title
Incidence of de novo atrial fibrillation
Time Frame
From beginning of infusion until beginning of retrieval surgery
Title
Time from recruitment to the administration of the study drug
Time Frame
From randomization to 12 hours post randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne Julie Frenette, M.Sc
Organizational Affiliation
Hopital du Sacre-Coeur de Montreal
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopital du Sacré-Coeur de Montreal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4J1C5
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
31179831
Citation
Frenette AJ, Williamson D, Williams V, Lagace AM, Charbonney E, Serri K. A Pilot Randomized Controlled Trial Comparing Levothyroxine to Placebo in Neurologically Deceased Donors. Prog Transplant. 2019 Sep;29(3):261-268. doi: 10.1177/1526924819855083. Epub 2019 Jun 9.
Results Reference
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Learn more about this trial

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

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