The Effects of Inhaled Nitric Oxide After Fontan Operation

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2011-12-31

Brief Summary

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Pleural effusions continue to be a post-operative complication seen after Fontan operation. This study will examine the use inhaled nitric oxide (iNO) given for 54 hours after Fontan operation to improve fluid balance. The study hypothesis is that inhaled nitric oxide after Fontan operation will improve fluid balance, thus decreasing the incidence of pleural effusions and shortening hospital stay.

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Detailed Description

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Conditions

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Congenital Heart Defect

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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No Intervention/ historical control group

historical controls group of patients who did not receive iNO.

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention

Prospective group who received iNO.

Group Type EXPERIMENTAL

inhaled nitric oxide (iNO)

Intervention Type DRUG

Inhaled nitric oxide 40ppm for 48 hours followed by a 6-hour wean.

Interventions

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inhaled nitric oxide (iNO)

Inhaled nitric oxide 40ppm for 48 hours followed by a 6-hour wean.

Intervention Type DRUG

Other Intervention Names

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Inomax

Eligibility Criteria

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Inclusion Criteria

* Male/female patients
* Undergoing Fontan operation at the Nemours Cardiac Center at A. I. duPont Hospital for Children
* Written parental permission to participate in this research study