Fenoldopam in Pediatric Cardiac Surgery
June 26, 2012 updated by: Zaccaria Ricci, Bambino Gesù Hospital and Research Institute
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
80
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Lazio
-
Rome, Lazio, Italy, 00165
- Bambino Gesu Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 day to 1 year (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Placebo
Saline blinded infusion
|
Saline continuous infusion during cardiopulmonary by pass at 1 ml/h
Other Names:
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 Names:
|
|
Active Comparator: Fenoldopam
Drug infusion
|
Saline continuous infusion during cardiopulmonary by pass at 1 ml/h
Other Names:
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Reduction of urinary and/or serum levels of biomarker NGAL in treated group versus controls
Time Frame: End of surgery and 12 hours postoperatively
|
End of surgery and 12 hours postoperatively
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
End of surgery and 12 hours postoperatively
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Sergio Picardo, MD, Bambino Gesu Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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. doi: 10.1186/cc6192.
- 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. doi: 10.1510/icvts.2008.185025. Epub 2008 Sep 9.
- 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. doi: 10.1186/cc10295.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2009
Primary Completion (Actual)
September 1, 2010
Study Completion (Actual)
November 1, 2010
Study Registration Dates
First Submitted
September 22, 2009
First Submitted That Met QC Criteria
September 22, 2009
First Posted (Estimate)
September 23, 2009
Study Record Updates
Last Update Posted (Estimate)
June 28, 2012
Last Update Submitted That Met QC Criteria
June 26, 2012
Last Verified
June 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FSCPB-1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.