Clinical Trials/NCT00982527

NCT00982527

Completed

Phase 3

Intraoperative Fenoldopam Infusion in Children Requiring Cardiopulmonary Bypass During Cardiac Surgery

Bambino Gesù Hospital and Research Institute1 site in 1 country80 target enrollmentSeptember 2009

ConditionsKidney Failure, Acute

InterventionsPlacebo Fenoldopam

DrugsPlacebo Fenoldopam

Overview

Phase: Phase 3
Intervention: Placebo
Conditions: Kidney Failure, Acute
Sponsor: Bambino Gesù Hospital and Research Institute
Enrollment: 80
Locations: 1
Primary Endpoint: Reduction of urinary and/or serum levels of biomarker NGAL in treated group versus controls
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 2009

End Date

November 2010

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Bambino Gesù Hospital and Research Institute

Responsible Party

Principal Investigator

Zaccaria Ricci

medical doctor

Bambino Gesù Hospital and Research Institute

Eligibility Criteria

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.

Arms & Interventions

Placebo

Saline blinded infusion

Intervention: Placebo

Placebo

Saline blinded infusion

Intervention: Fenoldopam

Fenoldopam

Drug infusion

Intervention: Placebo

Fenoldopam

Drug infusion

Intervention: Fenoldopam

Outcomes

Primary Outcomes

Reduction of urinary and/or serum levels of biomarker NGAL in treated group versus controls

Time Frame: End of surgery and 12 hours postoperatively

Secondary Outcomes

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)