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

Montreal Sacred Heart Hospital

Status and phase: Terminated; Phase 4

Conditions: Brain Dead Organ Donors

Treatments: Drug: placebo; Drug: Levothyroxine

Study type: Interventional

Funder types: Other

Identifiers

NCT02211053

2014-987

Details and patient eligibility

About

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

Enrollment: 15 patients

Sex: All

Ages: 16+ years old

Volunteers: No 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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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15 participants in 2 patient groups, including a placebo group

Levothyroxine

Active Comparator group

Description:

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

Treatment:

Drug: Levothyroxine

Placebo

Placebo Comparator group

Description:

Infusion matched to intervention arm

Treatment:

Drug: placebo