The Effects of Inhaled Nitric Oxide After Fontan Operation
Phase 2
Completed
- Conditions
- Congenital Heart Defect
- Interventions
- Drug: inhaled nitric oxide (iNO)
- Registration Number
- NCT00945529
- Lead Sponsor
- Ellen Spurrier
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 21
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
Exclusion Criteria
- Any condition which the PI feels will interfere with the patient's safe and effective participation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Intervention inhaled nitric oxide (iNO) Prospective group who received iNO.
- Primary Outcome Measures
Name Time Method Length of Hospital Stay Following Fontan until hospital discharge
- Secondary Outcome Measures
Name Time Method Percent of Patients With Significant Pleural Fluid Collections That Required Thoracostomy Drainage 2 weeks Percent of patients with significant pleural fluid collections that required thoracostomy drainage
Trial Locations
- Locations (1)
A. I. duPont Hospital for Children/Nemours Cardiac Center
🇺🇸Wilmington, Delaware, United States