Furosemide Versus Ethacrynic Acid in Children With Congenital Heart Disease

Fluid Overload Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01628731
• Other study ID #: FUROCRYNIC trial-1
• Secondary ID: OBG DIURETICS
• Status: Completed
• Phase: Phase 3
• First received: June 24, 2012
• Last updated: July 23, 2014
• Start date: October 2012
• Est. completion date: November 2013

Study information

• Verified date: July 2014
• Source: Bambino Gesù Hospital and Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: November 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 10 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fluid Overload

Intervention

Drug:
• furosemide
furosemide, intravenous, continuous infusion, 0.2 mg/kg/h for 24 hours
• ethacrynic acid
ethacrynic acid, intravenous, continuous infusion, 0.2 mg/kg/h for 24 hours

Locations

Country	Name	City	State
Italy	Bambino Gesù Hospital	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Bambino Gesù Hospital and Research Institute

Country where clinical trial is conducted

Italy, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Mean creatinine and NGAL values	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	first 72 hours after Intensive Care Unit admission	No