Fenoldopam in Pediatric Cardiac Surgery

Phase 3

Completed

• Conditions: Kidney Failure, Acute
• Interventions: Drug: Placebo; Drug: Fenoldopam

• Registration Number: NCT00982527
• Lead Sponsor: Bambino Gesù Hospital and Research Institute

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-09-22
• Study First Submitted QC: 2009-09-22
• Study First Posted: 2009-09-23
• Primary Completion: 2010-09
• Study Completion: 2010-11
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-26
• Last Update Posted: 2012-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Children with congenital heart disease, less than one year old, undergoing surgery with the use of cardiopulmonary bypass

Exclusion Criteria

• Children over one year old, correction for ventricular or atrial septal defect, need for deep hypothermic circulatory arrest, preoperative renal dysfunction.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fenoldopam	Placebo	Drug infusion
Placebo	Placebo	Saline blinded infusion
Placebo	Fenoldopam	Saline blinded infusion
Fenoldopam	Fenoldopam	Drug infusion

Primary Outcome Measures

Name	Time	Method
Reduction of urinary and/or serum levels of biomarker NGAL in treated group versus controls	End of surgery and 12 hours postoperatively

Secondary Outcome Measures

Name	Time	Method
Reduction of urinary and/or serum levels of cystatin C, increase of diuresis and improvement of perfusion markers in treated group versus controls	End of surgery and 12 hours postoperatively

Trial Locations

Locations (1)

Bambino Gesù Hospital; 🇮🇹 Rome, Lazio, Italy