NCT00982527

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Sep 2009

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

September 22, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 23, 2009

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

June 28, 2012

Status Verified

June 1, 2012

Enrollment Period

1 year

First QC Date

September 22, 2009

Last Update Submit

June 26, 2012

Conditions

Kidney Failure, Acute

Keywords

cardiopulmonary bypasspediatric cardiac surgeryacute renal failurerenal biomarkersfenoldopamFocus on optimization of perfusion during pediatric CPB

Outcome Measures

Primary Outcomes (1)

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

    End of surgery and 12 hours postoperatively

Secondary Outcomes (1)

  • Reduction of urinary and/or serum levels of cystatin C, increase of diuresis and improvement of perfusion markers in treated group versus controls

    End of surgery and 12 hours postoperatively

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Saline blinded infusion

Drug: PlaceboDrug: Fenoldopam

Fenoldopam

ACTIVE COMPARATOR

Drug infusion

Drug: PlaceboDrug: Fenoldopam

Interventions

PlaceboDRUG

Saline continuous infusion during cardiopulmonary by pass at 1 ml/h

Also known as: saline
FenoldopamPlacebo
FenoldopamDRUG

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.

Also known as: corlopam
FenoldopamPlacebo

Eligibility Criteria

Age1 Day - 365 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children with congenital heart disease, less than one year old, undergoing surgery with the use of cardiopulmonary bypass

You may not qualify if:

  • Children over one year old, correction for ventricular or atrial septal defect, need for deep hypothermic circulatory arrest, preoperative renal dysfunction.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bambino Gesù Hospital

Rome, Lazio, 00165, Italy

Location

Related Publications (4)

  • 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.

    PMID: 18070344BACKGROUND

  • 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.

    PMID: 18782787BACKGROUND

  • Esezobor CI, Bhatt GC, Effa EE, Hodson EM. Fenoldopam for preventing and treating acute kidney injury. Cochrane Database Syst Rev. 2024 Nov 28;11(11):CD012905. doi: 10.1002/14651858.CD012905.pub2.

    PMID: 39607014DERIVED

  • 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.

    PMID: 21714857DERIVED

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Sodium ChlorideFenoldopam

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Zaccaria Ricci, MD

    Bambino Gesu Hospital

    PRINCIPAL INVESTIGATOR

  • Sergio Picardo, MD

    Bambino Gesù Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
medical doctor

Study Record Dates

First Submitted

September 22, 2009

First Posted

September 23, 2009

Study Start

September 1, 2009

Primary Completion

September 1, 2010

Study Completion

November 1, 2010

Last Updated

June 28, 2012

Record last verified: 2012-06

Locations

IT(1)