NCT02975999

Use of Vasopressin Following the Fontan Operation

Use of Vasopressin Following the Fontan Operation: Both Pilot and Multicenter Studies

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Months – 7 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

A pilot 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. 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.

Conditions

• Pleural Effusion
• Single-ventricle

Interventions

Type	Name	Description
DRUG	Vasopressin	Vasopressin at dose of 0.4mU/kg/min will be started on the assigned group once coming off cardiopulmonary bypass following the Fontan operation.
DRUG	Normal Saline	Normal saline at starting dose of 0.4mU/kg/min will be started on the assigned group once coming off cardiopulmonary bypass following the Fontan operation.

Timeline

• Start date: 2016-12-01
• Primary completion: 2019-12-01
• Completion: 2019-12-01
• First posted: 2016-11-29
• Last updated: 2024-10-24
• Results posted: 2024-10-09

Locations

1 site across 1 country: United States