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TerminatedNCT02211053ECHOT4Updated Jul 17, 2018

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

A Phase 4 interventional study of Levothyroxine and placebo in Brain Dead Organ Donors, sponsored by Hopital du Sacre-Coeur de Montreal. Terminated at 1 site in Canada. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2018-07-17.

Sponsored by Hopital du Sacre-Coeur de Montreal · Phase 4, Interventional, and Supportive care

Why this study was terminated
Recruitment was too slow and we cannot anticipate to recruit the target sample size
Phase
Phase 4
Study type
Interventional
Enrollment
15
Allocation
Randomized
Ages
16 Years and older
Sex
All
01

Study 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

02

Conditions studied

  • Brain Dead Organ Donors

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Keywords

  • Organ donation
  • Brain dead
  • Levothyroxine
03

In context

Brain Death

74 studies on the registry are indexed under Brain Death; 9 are open to participants now.

This study's enrollment of 15 is below the median of 46 across 37 interventional studies indexed under Brain Death.

Browse Brain Death studies →

Lead sponsor

Hopital du Sacre-Coeur de Montreal is the lead sponsor of 21 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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)
05

Study design

Phase
Phase 4
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
15 participants (actual)

Study arms

  • Active comparator
    Levothyroxine

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

    Drug: Levothyroxine

  • Placebo comparator
    Placebo

    Infusion matched to intervention arm

    Drug: placebo

Interventions

  • DrugLevothyroxine

    20 mg IV bolus + 10 mg/h infusion

    Also known as: Synthroid(R)

  • Drugplacebo
06

What researchers measure

Primary outcomes

  1. Study feasibility

    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

  2. Variation in left ventricular ejection fraction

    Time frame: 6 hours post infusion

Secondary outcomes

  1. Numbers of donated hearts

    Time frame: On organ donation surgery

  2. Incidence of de novo atrial fibrillation

    Time frame: From beginning of infusion until beginning of retrieval surgery

  3. Time from recruitment to the administration of the study drug

    Time frame: From randomization to 12 hours post randomization

07

Study locations

1 site
  • Hopital du Sacré-Coeur de Montreal
    Montreal, Quebec H4J1C5, Canada
08

References and documents

Publications

  • 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. PubMed 31179831 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 17, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02211053
Lead sponsor
Hopital du Sacre-Coeur de Montreal
Responsible party
Anne Julie Frenette (Intensive Care Pharmacist, Associate Clinical Professor, Hopital du Sacre-Coeur de Montreal) — Principal investigator
First posted
Aug 7, 2014
Start date
Jul 2014
Primary completion
Dec 2016
Completion
Dec 2016
Last update
Jul 17, 2018

Study contacts

Anne Julie Frenette, M.Sc
principal investigator · Hopital du Sacre-Coeur de Montreal

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.

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Discussion

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