At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 80 enrolled
Drug / intervention
Placebo +1 moredrug
Likely dose
Placebo 1 mlfrom 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.
Intraoperative Fenoldopam Infusion in Children Requiring Cardiopulmonary Bypass During Cardiac Surgery
Bambino Gesù Hospital and Research Institute·interventional·Posted Sep 23, 2009·Updated Jun 28, 2012
In Brief
A Phase 3 clinical trial evaluating Placebo and Fenoldopam for Kidney Failure, Acute. Completed, enrolled 80 participants across 1 site.
Detailed Summary
The purpose of this study is to determine whether fenoldopam infusion during cardiopulmonary bypass in young children with congenital heart disease is able to reduce indicators of acute kidney injury (biomarkers reduction, diuresis increase) compared to a control group.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsKidney Failure, Acute
CountriesItaly
Collaborators--
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartSep 2009
First PostedSep 2009
Primary CompletionSep 2010
Study CompletionNov 2010
TodayJul 2026
First PostedSep 23, 2009
Enrollment StartSep 1, 2009
Primary CompletionSep 1, 2010
Study CompletionNov 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 16.8 years ago
Interventions
Placebodrug
Saline continuous infusion during cardiopulmonary by pass at 1 ml/h
Fenoldopamdrug
Fenoldopam continuous infusion at 1 mcg/kg/min during cardiopulmonary bypass. Infusion preparation is mad in order to match the rate 1 ml/h of placebo infusion.