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

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

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02211053

Acronym

ECHOT4

Enrollment

Registered

2014-08-07

Start date

2014-07-31

Completion date

2016-12-31

Last updated

2018-07-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Dead Organ Donors

Keywords

Organ donation, Brain dead, Levothyroxine

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

Interventions

DRUGLevothyroxine

20 mg IV bolus + 10 mg/h infusion

DRUGplacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

16 Years to No maximum

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)

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame
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

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026