At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 21 enrolled
Drug / intervention
inhaled nitric oxide (iNO)drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
The Effects of Inhaled Nitric Oxide on Patient Morbidity and Length of Hospital Stay Following Fontan Operation
In Brief
A Phase 3 clinical trial evaluating inhaled nitric oxide (iNO) for Congenital Heart Defect. Completed, enrolled 21 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCongenital Heart Defect
CountriesUnited States
CollaboratorsMallinckrodt
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartFeb 2008
First PostedJul 2009
Primary CompletionDec 2011
TodayJul 2026
First PostedJul 24, 2009
Enrollment StartFeb 1, 2008
Primary CompletionDec 1, 2011
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 16.9 years ago
Interventions
inhaled nitric oxide (iNO)drug
Inhaled nitric oxide 40ppm for 48 hours followed by a 6-hour wean.