NCT01628731

Brief Summary

This study aims to verify if ethacrynic acid continuous infusion is superior to furosemide continuous infusion in total urine output production during the first 24 post operative hours.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
74

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Oct 2012

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

First Submitted

Initial submission to the registry

June 24, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 27, 2012

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2012

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

July 24, 2014

Status Verified

July 1, 2014

Enrollment Period

9 months

First QC Date

June 24, 2012

Last Update Submit

July 23, 2014

Conditions

Fluid Overload

Keywords

loop diureticsfluid balanceurine outputacute renal dysfunction

Outcome Measures

Primary Outcomes (1)

  • Mean total urine output production in the first post-operative day

    Verification of the superiority of ethacrynic acid compared with furosemide in improving patients' total urine output by at least 1 ml/kg/h in the first 24 post-operative hours

    first 24 hours after Intensive Care Unit admission

Secondary Outcomes (1)

  • Mean creatinine and NGAL values

    first 72 hours after Intensive Care Unit admission

Study Arms (2)

furosemide

ACTIVE COMPARATOR

furosemide, 0.2 mg/kg/h up to 0.8 mg/kg/h for 72 hours

Drug: furosemide

ethacryinic acid

ACTIVE COMPARATOR

ethacrynic acid, 0.2 mg/kg/h up to 0.8 mg/kg/h for 72 hours

Drug: ethacrynic acid

Interventions

furosemideDRUG

furosemide, intravenous, continuous infusion, 0.2 mg/kg/h for 24 hours

Also known as: lasix
furosemide
ethacrynic acidDRUG

ethacrynic acid, intravenous, continuous infusion, 0.2 mg/kg/h for 24 hours

Also known as: reomax
ethacryinic acid

Eligibility Criteria

AgeUp to 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children with congenital heart disease undergoing cardiac surgery
  • intraoperative aortic cross clamp over 90 minutes or interventional catheterization procedures with post-operative inotrope score over 20
  • sign of fluid retention after surgical procedures

You may not qualify if:

  • Preoperative renal dysfunction
  • Preoperative administration of more than 4mg/kg/die loop diuretics
  • Need for renal replacement therapy at ICU admission
  • Need for ECMO at ICU admission

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bambino Gesù Hospital

Rome, 00165, Italy

Location

Related Publications (4)

  • Klinge JM, Scharf J, Hofbeck M, Gerling S, Bonakdar S, Singer H. Intermittent administration of furosemide versus continuous infusion in the postoperative management of children following open heart surgery. Intensive Care Med. 1997 Jun;23(6):693-7. doi: 10.1007/s001340050395.

    PMID: 9255651BACKGROUND

  • van der Vorst MM, Ruys-Dudok van Heel I, Kist-van Holthe JE, den Hartigh J, Schoemaker RC, Cohen AF, Burggraaf J. Continuous intravenous furosemide in haemodynamically unstable children after cardiac surgery. Intensive Care Med. 2001 Apr;27(4):711-5. doi: 10.1007/s001340000819.

    PMID: 11398698BACKGROUND

  • Bagshaw SM, Gibney RT, McAlister FA, Bellomo R. The SPARK Study: a phase II randomized blinded controlled trial of the effect of furosemide in critically ill patients with early acute kidney injury. Trials. 2010 May 11;11:50. doi: 10.1186/1745-6215-11-50.

    PMID: 20459801BACKGROUND

  • Ricci Z, Haiberger R, Pezzella C, Garisto C, Favia I, Cogo P. Furosemide versus ethacrynic acid in pediatric patients undergoing cardiac surgery: a randomized controlled trial. Crit Care. 2015 Jan 7;19(1):2. doi: 10.1186/s13054-014-0724-5.

    PMID: 25563826DERIVED

MeSH Terms

Conditions

Edema

Interventions

FurosemideEthacrynic Acid

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

SulfanilamidesSulfonamidesAmidesOrganic ChemicalsAniline CompoundsAminesSulfonesSulfur CompoundsPhenoxyacetatesGlycolatesAcetatesAcids, AcyclicCarboxylic AcidsHydroxy Acids

Study Officials

  • Zaccaria Ricci, MD

    Bambino Gesù Hospital RI

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor, Research Fellow

Study Record Dates

First Submitted

June 24, 2012

First Posted

June 27, 2012

Study Start

October 1, 2012

Primary Completion

July 1, 2013

Study Completion

November 1, 2013

Last Updated

July 24, 2014

Record last verified: 2014-07

Locations

IT(1)