Use of Vasopressin Following the Fontan Operation

Status Withdrawn

Clinical Trial Summary

The purpose of this study is to determine whether Vasopressin following the Fontan operation will decrease chest tube output and duration.

Clinical Trial Description

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. Vasopressin levels will be obtained just prior to initiation of Vasopressin and 48 hours later 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 0.4 mU/kg/min will be started on subjects in the study group while coming off cardiopulmonary bypass. The dose of Vasopressin will not be titrated. Study drug drip will infuse for 48 hours after which will be discontinued. The placebo group will be receiving normal saline at the same rate of the vasopressin group. The treating physician will be blinded. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02975999
Study type	Interventional
Source	Advocate Health Care
Contact
Status	Withdrawn
Phase	Phase 2/Phase 3
Start date	December 2016
Completion date	December 2019

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