The Effects of Inhaled Nitric Oxide After Fontan Operation

Congenital Heart Defect Clinical Trial

Official title:

The Effects of Inhaled Nitric Oxide on Patient Morbidity and Length of Hospital Stay Following Fontan Operation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00945529
• Other study ID #: SPURE1
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: February 2008
• Est. completion date: December 2011

Study information

• Verified date: April 2023
• Source: Nemours Children's Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 5 Years

Eligibility

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

Related Conditions & MeSH terms

• Congenital Heart Defect
• Heart Defects, Congenital

Intervention

Drug:
• inhaled nitric oxide (iNO)
Inhaled nitric oxide 40ppm for 48 hours followed by a 6-hour wean.

Locations

Country	Name	City	State
United States	A. I. duPont Hospital for Children/Nemours Cardiac Center	Wilmington	Delaware

Sponsors (2)

Lead Sponsor	Collaborator
Ellen Spurrier	Mallinckrodt

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of Hospital Stay Following Fontan		until hospital discharge
Secondary	Percent of Patients With Significant Pleural Fluid Collections That Required Thoracostomy Drainage	Percent of patients with significant pleural fluid collections that required thoracostomy drainage	2 weeks