Back to resultsThe Effects of Inhaled Nitric Oxide After Fontan Operation
Primary Purpose
Congenital Heart Defect
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
inhaled nitric oxide (iNO)
Sponsored by
About this trial
This is an interventional treatment trial for Congenital Heart Defect focused on measuring Fontan
Eligibility Criteria
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
Sites / Locations
- A. I. duPont Hospital for Children/Nemours Cardiac Center
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
No Intervention/ historical control group
Intervention
Arm Description
historical controls group of patients who did not receive iNO.
Prospective group who received iNO.
Outcomes
Primary Outcome Measures
Length of Hospital Stay Following Fontan
Secondary Outcome Measures
Percent of Patients With Significant Pleural Fluid Collections That Required Thoracostomy Drainage
Percent of patients with significant pleural fluid collections that required thoracostomy drainage
Full Information
NCT ID
NCT00945529
First Posted
May 28, 2009
Last Updated
April 26, 2023
Sponsor
Ellen Spurrier
Collaborators
Mallinckrodt
1. Study Identification
Unique Protocol Identification Number
NCT00945529
Brief Title
The Effects of Inhaled Nitric Oxide After Fontan Operation
Official Title
The Effects of Inhaled Nitric Oxide on Patient Morbidity and Length of Hospital Stay Following Fontan Operation
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ellen Spurrier
Collaborators
Mallinckrodt
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Heart Defect
Keywords
Fontan
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
No Intervention/ historical control group
Arm Type
No Intervention
Arm Description
historical controls group of patients who did not receive iNO.
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Prospective group who received iNO.
Intervention Type
Drug
Intervention Name(s)
inhaled nitric oxide (iNO)
Other Intervention Name(s)
Inomax
Intervention Description
Inhaled nitric oxide 40ppm for 48 hours followed by a 6-hour wean.
Primary Outcome Measure Information:
Title
Length of Hospital Stay Following Fontan
Time Frame
until hospital discharge
Secondary Outcome Measure Information:
Title
Percent of Patients With Significant Pleural Fluid Collections That Required Thoracostomy Drainage
Description
Percent of patients with significant pleural fluid collections that required thoracostomy drainage
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ellen Spurrier, MD
Organizational Affiliation
Nemours Children's Clinic - A. I. duPont Hospital for Children
Official's Role
Principal Investigator
Facility Information:
Facility Name
A. I. duPont Hospital for Children/Nemours Cardiac Center
City
Wilmington
State/Province
Delaware
ZIP/Postal Code
19803
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effects of Inhaled Nitric Oxide After Fontan Operation
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