Fenoldopam in Pediatric Cardiac Surgery

Sponsor

Bambino Gesù Hospital and Research Institute (Other)

Overall Status

Completed

CT.gov ID

NCT00982527

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

5.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Kidney Failure, Acute	Drug: Placebo Drug: Fenoldopam	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Care Provider)

Primary Purpose:

Treatment

Official Title:

Intraoperative Fenoldopam Infusion in Children Requiring Cardiopulmonary Bypass During Cardiac Surgery

Study Start Date :

Sep 1, 2009

Actual Primary Completion Date :

Sep 1, 2010

Actual Study Completion Date :

Nov 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo Saline blinded infusion	Drug: Placebo Saline continuous infusion during cardiopulmonary by pass at 1 ml/h Other Names: saline 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. Other Names: corlopam
Active Comparator: Fenoldopam Drug infusion	Drug: Placebo Saline continuous infusion during cardiopulmonary by pass at 1 ml/h Other Names: saline 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. Other Names: corlopam

Arm

Intervention/Treatment

Placebo Comparator: Placebo

Saline blinded infusion

Drug: Placebo

Saline continuous infusion during cardiopulmonary by pass at 1 ml/h

Other Names:

saline

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.

Other Names:

corlopam

Active Comparator: Fenoldopam

Drug infusion

Drug: Placebo

Saline continuous infusion during cardiopulmonary by pass at 1 ml/h

Other Names:

saline

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.

Other Names:

corlopam

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Day to 365 Days

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.