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

September 22, 2009
June 26, 2012
September 2009
September 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00982527 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Fenoldopam in Pediatric Cardiac Surgery
Intraoperative Fenoldopam Infusion in Children Requiring Cardiopulmonary Bypass During Cardiac Surgery

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Kidney Failure, Acute
  • 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
  • Placebo Comparator: Placebo
    Saline blinded infusion
    Interventions:
    • Drug: Placebo
    • Drug: Fenoldopam
  • Active Comparator: Fenoldopam
    Drug infusion
    Interventions:
    • Drug: Placebo
    • Drug: Fenoldopam

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
November 2010
September 2010   (final data collection date for primary outcome measure)

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.
Both
up to 365 Days
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00982527
FSCPB-1
No
Zaccaria Ricci, Bambino Gesù Hospital and Research Institute
Bambino Gesù Hospital and Research Institute
Not Provided
Principal Investigator: Zaccaria Ricci, MD Bambino Gesu Hospital
Study Director: Sergio Picardo, MD Bambino Gesù Hospital
Bambino Gesù Hospital and Research Institute
June 2012

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