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

Tracking Information

First Received Date ^ICMJE

September 22, 2009

Last Updated Date

June 26, 2012

Start Date ^ICMJE

September 2009

Primary Completion Date

September 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00982527 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Fenoldopam in Pediatric Cardiac Surgery

Official Title ^ICMJE

Intraoperative Fenoldopam Infusion in Children Requiring Cardiopulmonary Bypass During Cardiac Surgery

Brief 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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

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

Condition ^ICMJE

Kidney Failure, Acute

Intervention ^ICMJE

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

Study Arm (s)

Placebo Comparator: Placebo
Saline blinded infusion
Interventions:
- Drug: Placebo
- Drug: Fenoldopam
Active Comparator: Fenoldopam
Drug infusion
Interventions:
- Drug: Placebo
- Drug: Fenoldopam

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

November 2010

Primary Completion Date

September 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

up to 365 Days

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Italy

Administrative Information

NCT Number ^ICMJE

NCT00982527

Other Study ID Numbers ^ICMJE

FSCPB-1

Has Data Monitoring Committee

Responsible Party

Zaccaria Ricci, Bambino Gesù Hospital and Research Institute

Study Sponsor ^ICMJE

Bambino Gesù Hospital and Research Institute

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

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

Information Provided By

Bambino Gesù Hospital and Research Institute

Verification Date

June 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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