Fenoldopam in Pediatric Cardiac Surgery

Kidney Failure, Acute Clinical Trial

Official title:

Intraoperative Fenoldopam Infusion in Children Requiring Cardiopulmonary Bypass During Cardiac Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00982527
• Other study ID #: FSCPB-1
• Status: Completed
• Phase: Phase 3
• First received: September 22, 2009
• Last updated: June 26, 2012
• Start date: September 2009
• Est. completion date: November 2010

Study information

• Verified date: June 2012
• Source: Bambino Gesù Hospital and Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: November 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 365 Days

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Kidney Failure, Acute
• Renal Insufficiency

Intervention

Drug:
• Placebo
Saline continuous infusion during cardiopulmonary by pass at 1 ml/h
• 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.

Locations

Country	Name	City	State
Italy	Bambino Gesù Hospital	Rome	Lazio

Sponsors (1)

Lead Sponsor	Collaborator
Bambino Gesù Hospital and Research Institute

Country where clinical trial is conducted

Italy, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of urinary and/or serum levels of biomarker NGAL in treated group versus controls		End of surgery and 12 hours postoperatively	No
Secondary	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	No