Use of Vasopressin Following the Fontan Operation

Pleural Effusion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02975999
• Other study ID #: HRP-530
• Status: Withdrawn
• Phase: Phase 2/Phase 3
• Start date: December 2016
• Est. completion date: December 2019

Study information

• Verified date: December 2022
• Source: Advocate Health Care
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Months to 7 Years

Eligibility

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

Related Conditions & MeSH terms

• Pleural Effusion
• Single-ventricle
• Univentricular Heart

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Advocate Children's Hospital	Oak Lawn	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Advocate Health Care

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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