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Furosemide Versus Ethacrynic Acid in Children With Congenital Heart Disease

This study is currently recruiting participants.
Verified December 2012 by Bambino Gesù Hospital and Research Institute
Sponsor:
Information provided by (Responsible Party):
Zaccaria Ricci, Bambino Gesù Hospital and Research Institute
ClinicalTrials.gov Identifier:
NCT01628731
First received: June 24, 2012
Last updated: December 29, 2012
Last verified: December 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Fluid Overload
 Drug: furosemide
Drug: ethacrynic acid
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase III Study of Furosemide Continuous Infusion Versus Ethacrynic Acid Continuous Infusion in Children Undergoing Cardiac Surgery: Randomized Double Blind Controlled Clinical Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bambino Gesù Hospital and Research Institute:

Primary Outcome Measures:
  • Mean total urine output production in the first post-operative day [ Time Frame: first 24 hours after Intensive Care Unit admission ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Mean creatinine and NGAL values [ Time Frame: first 72 hours after Intensive Care Unit admission ] [ Designated as safety issue: No ]
    Verification of the superiority of ethacrynic acid compared with furosemide in improving patients' renal function (asessed as creatinine, NGAL and pRIFLE score) in the first 72 post-operative hours


Estimated Enrollment: 106
Study Start Date: October 2012
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: furosemide Drug: furosemide
furosemide, intravenous, continuous infusion, 0.2 mg/kg/h for 24 hours
Other Name: lasix
Active Comparator: ethacryinic acid Drug: ethacrynic acid
ethacrynic acid, intravenous, continuous infusion, 0.2 mg/kg/h for 24 hours
Other Name: reomax

Detailed Description:

Diuretic therapy in children after open heart surgery is widely administered, though no evidence currently supports if an ideal drug or an ideal dosage can be recommended. Loop diuretics are the most effective drugs in terms of urine output production but may cause some collateral effects such as metabolic alkalosis, hypovolemia, hypokalemia, ototoxicity. Furthermore, some reports showed that loop diuretics usage can be associated with an increased risk of renal dysfunction and mortality. However, their use in children with signs of fluid overload, pulmonary edema or oliguria is mandatory and widely practiced.

Furosemide and ethacrynic acid are often prescribed and administered without any specific indication, basing on clinicians preferences.

No study so far, explored the hypothesis of which of these drugs is the most effective in terms of urine output production and safe in terms of renal function.

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.

  Eligibility

Ages Eligible for Study:   up to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01628731

Contacts
Contact: Zaccaria Ricci, MD +39 0668592449 z.ricci@libero.it
Contact: Paola Cogo, MD +39 0668592449 paola.cogo@opbg.net

Locations
Italy
Bambino Gesù Hospital Recruiting
Rome, Italy, 00165
Contact: Zaccaria Ricci, MD     +390668592449     zaccaria.ricci@gmail.com    
Contact: paola E Cogo, PhD, MD     +390668592449     paola.cogo@opbg.net    
Sub-Investigator: Roberta Haiberger, MD            
Sponsors and Collaborators
Bambino Gesù Hospital and Research Institute
Investigators
Principal Investigator: Zaccaria Ricci, MD Bambino Gesù Hospital RI
  More Information

Publications:

Responsible Party: Zaccaria Ricci, Medical Doctor, Research Fellow, Bambino Gesù Hospital and Research Institute
ClinicalTrials.gov Identifier: NCT01628731     History of Changes
Other Study ID Numbers: FUROCRYNIC trial-1, OBG DIURETICS
Study First Received: June 24, 2012
Last Updated: December 29, 2012
Health Authority: Italy: Ethics Committee

Keywords provided by Bambino Gesù Hospital and Research Institute:
loop diuretics
fluid balance
urine output
acute renal dysfunction

Additional relevant MeSH terms:
Water Intoxication
Water-Electrolyte Imbalance
Metabolic Diseases
Poisoning
Substance-Related Disorders
Ethacrynic Acid
Furosemide
Diuretics
Natriuretic Agents
 Physiological Effects of Drugs
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Therapeutic Uses
Sodium Potassium Chloride Symporter Inhibitors
Membrane Transport Modulators

ClinicalTrials.gov processed this record on May 16, 2013