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

Information source: Hopital du Sacre-Coeur de Montreal
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Brain Dead Organ Donors

Intervention: Levothyroxine (Drug); placebo (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Hopital du Sacre-Coeur de Montreal

Official(s) and/or principal investigator(s):
Anne Julie Frenette, M.Sc, Principal Investigator, Affiliation: Hopital du Sacre-Coeur de Montreal


The purpose of this study is to evaluate if the administration of an infusion of levothyroxine can improve heart function in organ donors

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Primary outcome: Variation in left ventricular ejection fraction

Secondary outcome:

Variation of cardiac index defined as the difference in cardiac index (L/min)

Variation of inotrope and vasopressor doses defined as the difference in mean hour-dose of milrinone, noradrenaline, vasopressin and/or phenylephrine

Converted organs defined as the number of converted hearts according to standard Transplant-Quebec definition and total retrieved organs

Incidence of de novo atrial fibrillation

Survival of liver recipients

Serum levels of thyroid hormones levels


Minimum age: 16 Years. Maximum age: 74 Years. Gender(s): Both.


Inclusion Criteria:

- Prior signed written informed from family member

- 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

- Chronic exogenous oral T4 or T3 before death

- Having received T4 infusion before recruitment

- Echographic images not interpretable

- Age 75 and older

- Prior coronary heart disease defined as prior coronary artery bypass graft or

percutaneous coronary intervention (with or without stents)

Locations and Contacts

Hopital du Sacré-Coeur de Montreal, Montreal, Quebec H4J1C5, Canada; Recruiting
Anne Julie Frenette, M.Sc, Phone: 514-338-2222, Ext: 2666, Email: anne.julie.frenette@umontreal.ca
Anne Julie Frenette, M.Sc, Principal Investigator
Additional Information

Starting date: July 2014
Last updated: August 5, 2014

Page last updated: August 23, 2015

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