Fenoldopam in Pediatric Cardiac Surgery

Bambino Gesù Hospital and Research Institute

Status and phase: Completed; Phase 3

Conditions: Kidney Failure, Acute

Treatments: Drug: Fenoldopam; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00982527

FSCPB-1

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 1 to 365 days old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Saline blinded infusion

Treatment:

Drug: Placebo

Drug: Fenoldopam

Fenoldopam

Active Comparator group

Description:

Drug infusion

Treatment:

Drug: Placebo

Drug: Fenoldopam