NCT01628731

Furosemide Versus Ethacrynic Acid in Children With Congenital Heart Disease

Phase III Study of Furosemide Continuous Infusion Versus Ethacrynic Acid Continuous Infusion in Children Undergoing Cardiac Surgery: Randomized Double Blind Controlled Clinical Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: Bambino Gesù Hospital and Research Institute · Academic / Other
• Sex: All
• Age: 10 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Fluid Overload

Interventions

Type	Name	Description
DRUG	furosemide	furosemide, intravenous, continuous infusion, 0.2 mg/kg/h for 24 hours
DRUG	ethacrynic acid	ethacrynic acid, intravenous, continuous infusion, 0.2 mg/kg/h for 24 hours

Timeline

• Start date: 2012-10-01
• Primary completion: 2013-07-01
• Completion: 2013-11-01
• First posted: 2012-06-27
• Last updated: 2014-07-24

Locations

1 site across 1 country: Italy