Clinical Trial: Evaluation of the Efficacy and Safety of Levothyroxine in Brain Death Organ Donors: a Randomized Controled Trial
Study Status: Suspended
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Evaluation of the Efficacy and Safety of Levothyroxine in Brain Death Organ Donors: a Randomized Controlled Trial
Brief Summary: The purpose of this study is to evaluate if the administration of an infusion of levothyroxine can improve heart function in organ donors
Detailed Summary:
Sponsor: Hopital du Sacre-Coeur de Montreal
Current Primary Outcome: Variation in left ventricular ejection fraction [ Time Frame: 6 hours post infusion ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Variation of cardiac index defined as the difference in cardiac index (L/min) [ Time Frame: 6 hours post infusion ]
- Variation of inotrope and vasopressor doses defined as the difference in mean hour-dose of milrinone, noradrenaline, vasopressin and/or phenylephrine [ Time Frame: 6 hours post infusion ]
- Converted organs defined as the number of converted hearts according to standard Transplant-Quebec definition and total retrieved organs [ Time Frame: 24 hours post infusion or at the beginning of retrieval surgery, whatever comes first ]
- Incidence of de novo atrial fibrillation [ Time Frame: From beginning of infusion until beginning of retrieval surgery ]
- Survival of liver recipients [ Time Frame: 6 months post transplant ]
- Serum levels of thyroid hormones levels [ Time Frame: Immediately before infusion, 6 hours post infusion and 24 hours post infusion ]
Original Secondary Outcome: Same as current
Information By: Hopital du Sacre-Coeur de Montreal
Dates:
Date Received: August 1, 2014
Date Started: July 2014
Date Completion:
Last Updated: August 5, 2014
Last Verified: August 2014
