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

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

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

Conditions
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Brain Dead Organ Donors

Intervention / Treatment
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* Drug: Levothyroxine
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Levothyroxine<br>Levothyroxine infusion 20 mg IV bolus then 10 mg/h infusion | Drug: Levothyroxine<br>* 20 mg IV bolus + 10 mg/h infusion<br>* Other names: Synthroid(R);|
| Placebo Comparator: Placebo<br>Infusion matched to intervention arm | Drug: placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Study feasibility | 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 |  | 6 hours post infusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Organ donation, Brain dead, Levothyroxine