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The purpose of this study is to determine whether Vasopressin following the Fontan operation will decrease chest tube output and duration.
A pilot and subsequently a multicenter, randomized, double blinded clinical trial to evaluate the use of vasopressin following the Fontan operation.
Phase one of the study will be a single center pilot study and will be conducted at Advocate Children's Hospital, Oak Lawn IL. This will be a randomized and double blinded. Ten patients will be enrolled with five patients as control group and five receiving Vasopressin. The same protocol will be used for both phases of the study. Vasopressin levels will be obtained just prior to initiation of Vasopressin in the pilot study. Safety and effect size will be evaluated after this pilot study.
The multicenter study will be phase two and will be conducted in the cardiac operating rooms and cardiac intensive care unit (CVICU) of 7 pediatric cardiovascular programs in the United States. The investigators will be enrolling 12 subjects undergoing the Fontan operation from each participating institution. Six patients will be randomly assigned to receive Vasopressin while six will receive placebo.
A total of 84 patients undergoing the Fontan operation will be included in the study and randomized to one of the two treatment groups.
Group 1 will include 42 subjects who will receive the treatment drug (Vasopressin) for 48 hours following the Fontan operation. Group 2 will include 42 subjects who will receive placebo (normal saline) and will serve as a control group.
Drug administration protocol:
Vasopressin at a dose of 0.3 mU/kg/min will be started on subjects in the study group while coming off cardiopulmonary bypass. The dose of Vasopressin will be titrated in the CVICU to a maximum of 0.5 mU/kg/min according to blood pressure and clinical perfusion. The drip will eventually be titrated down to 0.3 mU/kg/min and from that dose will be discontinued 48 hours after arrival in the CVICU.
The placebo group will be receiving normal saline and that can also be titrated at the same 'dose' of the Vasopressin group. The treating physician will be blinded.
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Vasopressin, Normal Saline
Advocate Children's Hospital
Not yet recruiting
Advocate Health Care
Published on BioPortfolio: 2016-11-30T15:45:40-0500
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