Use of Vasopressin Following the Fontan Operation

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

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

Study Overview

• Status: Withdrawn
• Conditions: Single-ventricle; Pleural Effusion
• Intervention / Treatment: Drug: Vasopressin; Drug: Normal Saline

Detailed 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 Type: Interventional
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Oak Lawn, Illinois, United States, 60453
      • Advocate Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 5 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vasopressin; Vasopressin at 0.4mU/kg/min	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.; Other Names: Vasostrict, arginine
Placebo Comparator: Normal saline; Normal saline will be provided on a drip infusion to the selected 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.; Other Names: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Chest tube drainage	chest tube drainage in ml/kg/day until the day the chest tube is removed	From post operative day 0 through study completion, an average of 1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of hospital stay	Duration the patient remains in the hospital in days until the day of discharge home	From the day of the surgery (post operative day 0) through study completion, an average of 1 month

Collaborators and Investigators

• Sponsor: Advocate Health Care

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2016
• Primary Completion (Actual): December 1, 2019
• Study Completion (Actual): December 1, 2019

Study Registration Dates

• First Submitted: September 22, 2016
• First Submitted That Met QC Criteria: November 24, 2016
• First Posted (Estimate): November 29, 2016

Study Record Updates

• Last Update Posted (Actual): December 13, 2022
• Last Update Submitted That Met QC Criteria: December 10, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Respiratory Tract Diseases; Congenital Abnormalities; Pleural Diseases; Heart Defects, Congenital; Cardiovascular Abnormalities; Univentricular Heart; Pleural Effusion; Physiological Effects of Drugs; Natriuretic Agents; Hemostatics; Coagulants; Vasoconstrictor Agents; Antidiuretic Agents; Vasopressins; Arginine Vasopressin
• Other Study ID Numbers: HRP-530

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No