Phase 3
Completed N=44
The Effects of Inhaled Nitric Oxide After Fontan Operation
Source: ClinicalTrials.gov NCT00945529 ↗Enrolled (actual)
44
Serious AEs
29.5%
Results posted
May 2023
Primary outcomePrimary: Length of Hospital Stay Following Fontan — 11.2; 11 days
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Length of Hospital Stay Following Fontan |
11.2; 11 | — |
| SECONDARY Percent of Patients With Significant Pleural Fluid Collections That Required Thoracostomy Drainage |
43.5; 33.4 | — |
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
Data sourced from ClinicalTrials.gov (NCT00945529). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.