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Fenoldopam in Pediatric Cardiac Surgery

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ClinicalTrials.gov Identifier: NCT00982527
Recruitment Status : Completed
First Posted : September 23, 2009
Last Update Posted : June 28, 2012
Sponsor:
Information provided by (Responsible Party):
Zaccaria Ricci, Bambino Gesù Hospital and Research Institute

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.

Condition or disease Intervention/treatment Phase
Kidney Failure, Acute Drug: Placebo Drug: Fenoldopam Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Intraoperative Fenoldopam Infusion in Children Requiring Cardiopulmonary Bypass During Cardiac Surgery
Study Start Date : September 2009
Actual Primary Completion Date : September 2010
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Fenoldopam
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Reduction of urinary and/or serum levels of biomarker NGAL in treated group versus controls [ Time Frame: End of surgery and 12 hours postoperatively ]

Secondary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   up to 365 Days   (Child)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:
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
First Posted: September 23, 2009    Key Record Dates
Last Update Posted: June 28, 2012
Last Verified: June 2012

Keywords provided by Zaccaria Ricci, 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:
Renal Insufficiency
Acute Kidney Injury
Kidney Diseases
Urologic Diseases
Fenoldopam
Antihypertensive Agents
Vasodilator Agents
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs