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
  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:


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
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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:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 July 20, 2014