Use of Vasopressin Following the Fontan Operation

Wake Forest University Health Sciences12 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Pleural Effusion Single-ventricle

Interventions

VasopressinDRUG

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 SalineDRUG

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.

Eligibility

Sex: ALLMin age: 18 MonthsMax age: 7 Years

Medical Language ↔ Plain English

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

Locations (1)

Advocate Children's Hospital

Oak Lawn, Illinois, United States

Outcomes

Primary Outcomes

Chest Tube Drainage

chest tube drainage until the day the chest tube is removed

Time frame: From post operative day 0 through study completion, an average of 1 month

Secondary Outcomes

Length of Hospital Stay

Duration the patient remains in the hospital in days until the day of discharge home

Time frame: From the day of the surgery (post operative day 0) through study completion, an average of 1 month

Data from ClinicalTrials.gov

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