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Fenoldopam in Pediatric Cardiac Surgery

Information source: Bambino Ges¨ Hospital and Research Institute
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Kidney Failure, Acute

Intervention: Placebo (Drug); Fenoldopam (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Bambino Ges¨ Hospital and Research Institute

Official(s) and/or principal investigator(s):
Zaccaria Ricci, MD, Principal Investigator, Affiliation: Bambino Gesu Hospital
Sergio Picardo, MD, Study Director, Affiliation: Bambino Ges├╣ Hospital

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.

Clinical Details

Official title: Intraoperative Fenoldopam Infusion in Children Requiring Cardiopulmonary Bypass During Cardiac Surgery

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

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

Secondary outcome: Reduction of urinary and/or serum levels of cystatin C, increase of diuresis and improvement of perfusion markers in treated group versus controls

Eligibility

Minimum age: N/A. Maximum age: 365 Days. Gender(s): Both.

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.

Locations and Contacts

Bambino Ges├╣ Hospital, Rome, Lazio 00165, Italy
Additional Information

Related publications:

Dent CL, Ma Q, Dastrala S, Bennett M, Mitsnefes MM, Barasch J, Devarajan P. Plasma neutrophil gelatinase-associated lipocalin predicts acute kidney injury, morbidity and mortality after pediatric cardiac surgery: a prospective uncontrolled cohort study. Crit Care. 2007;11(6):R127.

Ricci Z, Stazi GV, Di Chiara L, Morelli S, Vitale V, Giorni C, Ronco C, Picardo S. Fenoldopam in newborn patients undergoing cardiopulmonary bypass: controlled clinical trial. Interact Cardiovasc Thorac Surg. 2008 Dec;7(6):1049-53. doi: 10.1510/icvts.2008.185025. Epub 2008 Sep 9.

Starting date: September 2009
Last updated: June 26, 2012

Page last updated: August 23, 2015

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