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Fenoldopam in Pediatric Cardiac Surgery

Primary Purpose

Kidney Failure, Acute

Status
Completed
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
Placebo
Fenoldopam
Sponsored by
Bambino Gesù Hospital and Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Failure, Acute focused on measuring cardiopulmonary bypass, pediatric cardiac surgery, acute renal failure, renal biomarkers, fenoldopam, Focus on optimization of perfusion during pediatric CPB

Eligibility Criteria

1 Day - 365 Days (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Bambino Gesù Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

Fenoldopam

Arm Description

Saline blinded infusion

Drug infusion

Outcomes

Primary Outcome Measures

Reduction of urinary and/or serum levels of biomarker NGAL in treated group versus controls

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

Full Information

First Posted
September 22, 2009
Last Updated
June 26, 2012
Sponsor
Bambino Gesù Hospital and Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT00982527
Brief Title
Fenoldopam in Pediatric Cardiac Surgery
Official Title
Intraoperative Fenoldopam Infusion in Children Requiring Cardiopulmonary Bypass During Cardiac Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
November 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bambino Gesù Hospital and Research Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Failure, Acute
Keywords
cardiopulmonary bypass, pediatric cardiac surgery, acute renal failure, renal biomarkers, fenoldopam, Focus on optimization of perfusion during pediatric CPB

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Saline blinded infusion
Arm Title
Fenoldopam
Arm Type
Active Comparator
Arm Description
Drug infusion
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
saline
Intervention Description
Saline continuous infusion during cardiopulmonary by pass at 1 ml/h
Intervention Type
Drug
Intervention Name(s)
Fenoldopam
Other Intervention Name(s)
corlopam
Intervention Description
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.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
365 Days
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zaccaria Ricci, MD
Organizational Affiliation
Bambino Gesu Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sergio Picardo, MD
Organizational Affiliation
Bambino Gesù Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Bambino Gesù Hospital
City
Rome
State/Province
Lazio
ZIP/Postal Code
00165
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
18070344
Citation
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.
Results Reference
background
PubMed Identifier
18782787
Citation
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.
Results Reference
background
PubMed Identifier
21714857
Citation
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.
Results Reference
derived

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Fenoldopam in Pediatric Cardiac Surgery

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