Use of Vasopressin Following the Fontan Operation

Phase 2

Completed

• Conditions: Pleural Effusion; Single-ventricle
• Interventions: Drug: Vasopressin; Drug: Normal Saline

• Registration Number: NCT02975999
• Lead Sponsor: Wake Forest University Health Sciences

Brief 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.

Study Timeline

• Study First Submitted: 2016-09-22
• Study First Submitted QC: 2016-11-24
• Study First Posted: 2016-11-29
• Study Start: 2016-12
• Primary Completion: 2019-12
• Study Completion: 2019-12
• Results First Submitted: 2023-08-09
• Status Verified: 2024-09
• Results First Submitted QC: 2024-09-18
• Results First Posted: 2024-10-09
• Last Update Submitted: 2024-10-22
• Last Update Posted: 2024-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• Subjects between 1.5-7 years old undergoing Fontan operation.

Exclusion Criteria

• Patients with a planned fenestrated Fontan.
• Patients undergoing revision surgery for failing Fontan.
• Evidence of renal insufficiency prior to surgery defined by creatinine >1 mg/dl.
• Planned arch reconstruction at the time of the Fontan procedure

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vasopressin	Vasopressin	Vasopressin at 0.4mU/kg/min
Normal saline	Normal Saline	Normal saline will be provided on a drip infusion to the selected group once coming off cardiopulmonary bypass following the Fontan operation.

Primary Outcome Measures

Name	Time	Method
Chest Tube Drainage	From post operative day 0 through study completion, an average of 1 month	chest tube drainage until the day the chest tube is removed

Secondary Outcome Measures

Name	Time	Method
Length of Hospital Stay	From the day of the surgery (post operative day 0) through study completion, an average of 1 month	Duration the patient remains in the hospital in days until the day of discharge home

Trial Locations

Locations (1)

Advocate Children's Hospital; 🇺🇸 Oak Lawn, Illinois, United States