Fenoldopam in Pediatric Cardiac Surgery

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Zaccaria Ricci, Bambino Gesù Hospital and Research Institute

ClinicalTrials.gov Identifier:

NCT00982527

First received: September 22, 2009

Last updated: June 26, 2012

Last verified: June 2012

History of Changes

Purpose

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.

Condition	Intervention	Phase
Kidney Failure, Acute	Drug: Placebo Drug: Fenoldopam	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver) Primary Purpose: Treatment
Official Title:	Intraoperative Fenoldopam Infusion in Children Requiring Cardiopulmonary Bypass During Cardiac Surgery

Resource links provided by NLM:

MedlinePlus related topics: Heart Surgery

Drug Information available for: Fenoldopam Fenoldopam mesylate

U.S. FDA Resources

Further study details as provided by Bambino Gesù Hospital and Research Institute:

Primary Outcome Measures:

Reduction of urinary and/or serum levels of biomarker NGAL in treated group versus controls [ Time Frame: End of surgery and 12 hours postoperatively ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Reduction of urinary and/or serum levels of cystatin C, increase of diuresis and improvement of perfusion markers in treated group versus controls [ Time Frame: End of surgery and 12 hours postoperatively ] [ Designated as safety issue: No ]

Enrollment:	80
Study Start Date:	September 2009
Study Completion Date:	November 2010
Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: Placebo Saline blinded infusion	Drug: Placebo Saline continuous infusion during cardiopulmonary by pass at 1 ml/h Other Name: saline 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. Other Name: corlopam
Active Comparator: Fenoldopam Drug infusion	Drug: Placebo Saline continuous infusion during cardiopulmonary by pass at 1 ml/h Other Name: saline 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. Other Name: corlopam

Eligibility

Ages Eligible for Study:	up to 365 Days
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00982527

Locations

Italy
Bambino Gesù Hospital
Rome, Lazio, Italy, 00165

Sponsors and Collaborators

Bambino Gesù Hospital and Research Institute

Investigators

Principal Investigator:	Zaccaria Ricci, MD	Bambino Gesu Hospital
Study Director:	Sergio Picardo, MD	Bambino Gesù Hospital

More Information

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.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Ricci Z, Luciano R, Favia I, Garisto C, Muraca M, Morelli S, Di Chiara L, Cogo P, Picardo S. High-dose fenoldopam reduces postoperative neutrophil gelatinase-associated lipocaline and cystatin C levels in pediatric cardiac surgery. Crit Care. 2011 Jun 29;15(3):R160.

Responsible Party:	Zaccaria Ricci, medical doctor, Bambino Gesù Hospital and Research Institute
ClinicalTrials.gov Identifier:	NCT00982527 History of Changes
Other Study ID Numbers:	FSCPB-1
Study First Received:	September 22, 2009
Last Updated:	June 26, 2012
Health Authority:	Italy: Ethics Committee

Keywords provided by Bambino Gesù Hospital and Research Institute:

cardiopulmonary bypass
pediatric cardiac surgery
acute renal failure

renal biomarkers
fenoldopam
Focus on optimization of perfusion during pediatric CPB

Additional relevant MeSH terms:

Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Fenoldopam
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses

Pharmacologic Actions
Vasodilator Agents
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 16, 2013

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