Use of Vasopressin Following the Fontan Operation

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2019-12-31

Brief Summary

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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.

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Detailed Description

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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

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Pleural Effusion Single-ventricle

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Vasopressin

Vasopressin at 0.4mU/kg/min

Group Type EXPERIMENTAL

Vasopressin

Intervention Type DRUG

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 will be provided on a drip infusion to the selected group once coming off cardiopulmonary bypass following the Fontan operation.

Group Type PLACEBO_COMPARATOR

Normal Saline

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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Vasostrict, arginine Placebo

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

Minimum Eligible Age

18 Months

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No