Fenoldopam in Pediatric Cardiac Surgery
Information source: Bambino Gesù Hospital and Research Institute
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Kidney Failure, Acute; Cardiopulmonary Bypass
Intervention: Placebo (Drug); Fenoldopam (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Bambino Gesù 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 Gesù Hospital
Overall contact:
Zaccaria Ricci, MD, Phone: +39 0668592449, Email: z.ricci@libero.it
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, Control: Placebo Control, 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
Zaccaria Ricci, MD, Phone: +39 0668592449, Email: z.ricci@libero.it
Bambino Gesù Hospital, Rome, Lazio 00165, Italy; Recruiting
Zaccaria Ricci, MD, Phone: +39 06 68592449, Email: z.ricci@libero.it
Zaccaria Ricci, MD, Principal Investigator
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. Epub 2008 Sep 9.
Starting date: September 2009
Last updated: May 25, 2010
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