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