The Effects of Inhaled Nitric Oxide After Fontan Operation
Sponsor
Nemours Children's Clinic (Other)
Overall Status
Completed
CT.gov ID
NCT00945529
Collaborator
Mallinckrodt (Industry)
21
1
64
0.3
Study Details
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 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2/Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
21 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Effects of Inhaled Nitric Oxide on Patient Morbidity and Length of Hospital Stay Following Fontan Operation
Study Start Date
:
Aug 1, 2006
Actual Primary Completion Date
:
Dec 1, 2011
Actual Study Completion Date
:
Dec 1, 2011
Outcome Measures
Primary Outcome Measures
- length of hospital stay following Fontan [2 weeks]
Secondary Outcome Measures
- Maximum post-op weight [2 weeks]
- Daily fluid balance [2 weeks]
- Magnitude of pleural fluid collection [2 weeks]
- Thoracentesis [2 weeks]
- Duration of pleural effusions [2 weeks]
Eligibility Criteria
Criteria
Ages Eligible for Study:
1 Year
to 5 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | A. I. duPont Hospital for Children/Nemours Cardiac Center | Wilmington | Delaware | United States | 19803 |
Sponsors and Collaborators
- Nemours Children's Clinic
- Mallinckrodt
Investigators
- Principal Investigator: Ellen Spurrier, MD, Nemours Children's Clinic - A. I. duPont Hospital for Children
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00945529
Other Study ID Numbers:
- SPURE1
First Posted:
Jul 24, 2009
Last Update Posted:
May 4, 2012
Last Verified:
May 1, 2012
Keywords provided by ,
,
Additional relevant MeSH terms: