NCT00982527

Fenoldopam in Pediatric Cardiac Surgery

Intraoperative Fenoldopam Infusion in Children Requiring Cardiopulmonary Bypass During Cardiac Surgery

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Bambino Gesù Hospital and Research Institute · Academic / Other
• Sex: All
• Age: 1 Day – 365 Days
• Healthy volunteers: Not accepted

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.

Conditions

• Kidney Failure, Acute

Interventions

Type	Name	Description
DRUG	Placebo	Saline continuous infusion during cardiopulmonary by pass at 1 ml/h
DRUG	Fenoldopam	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.

Timeline

• Start date: 2009-09-01
• Primary completion: 2010-09-01
• Completion: 2010-11-01
• First posted: 2009-09-23
• Last updated: 2012-06-28

Locations

1 site across 1 country: Italy