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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

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

Page last updated: August 23, 2015

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