Fenoldopam in Pediatric Cardiac Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2010-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Kidney Failure, Acute

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Placebo

Saline blinded infusion

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Fenoldopam

Intervention Type DRUG

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.

Fenoldopam

Drug infusion

Group Type ACTIVE_COMPARATOR

Placebo

Intervention Type DRUG

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

Fenoldopam

Intervention Type DRUG

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.

Interventions

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Placebo

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

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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saline corlopam

Eligibility Criteria

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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.

Minimum Eligible Age

1 Day

Maximum Eligible Age

365 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No