Furosemide Versus Ethacrynic Acid in Children With Congenital Heart Disease

Phase 3

Completed

• Conditions: Fluid Overload
• Interventions: Drug: furosemide; Drug: ethacrynic acid

• Registration Number: NCT01628731
• Lead Sponsor: Bambino Gesù Hospital and Research Institute

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.

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.

Study Timeline

• Study First Submitted: 2012-06-24
• Study First Submitted QC: 2012-06-26
• Study First Posted: 2012-06-27
• Study Start: 2012-10
• Primary Completion: 2013-07
• Study Completion: 2013-11
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-23
• Last Update Posted: 2014-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
furosemide	furosemide	furosemide, 0.2 mg/kg/h up to 0.8 mg/kg/h for 72 hours
ethacryinic acid	ethacrynic acid	ethacrynic acid, 0.2 mg/kg/h up to 0.8 mg/kg/h for 72 hours

Primary Outcome Measures

Name	Time	Method
Mean total urine output production in the first post-operative day	first 24 hours after Intensive Care Unit admission	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

Name	Time	Method
Mean creatinine and NGAL values	first 72 hours after Intensive Care Unit admission	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

Trial Locations

Locations (1)

Bambino Gesù Hospital; 🇮🇹 Rome, Italy