Use of Vasopressin Following the Fontan Operation

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

Detailed Description
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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.

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

Conditions
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Pleural Effusion, Single-ventricle

Intervention / Treatment
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* Drug: Vasopressin
* Drug: Normal Saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Months
Maximum Age: 7 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vasopressin<br>Vasopressin at 0.4mU/kg/min | Drug: Vasopressin<br>* Vasopressin at dose of 0.4mU/kg/min will be started on the assigned group once coming off cardiopulmonary bypass following the Fontan operation.<br>* Other names: Vasostrict, arginine;|
| Placebo Comparator: Normal saline<br>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<br>* 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.<br>* Other names: Placebo;|

What is the study measuring?
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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 |