Furosemide Versus Ethacrynic Acid in Children With Congenital Heart Disease

Bambino Gesù Hospital and Research Institute

Status and phase: Completed; Phase 3

Conditions: Fluid Overload

Treatments: Drug: ethacrynic acid; Drug: furosemide

Study type: Interventional

Funder types: Other

Identifiers

NCT01628731

FUROCRYNIC trial-1

OBG DIURETICS (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 74 patients

Sex: All

Ages: Under 10 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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74 participants in 2 patient groups

furosemide

Active Comparator group

Description:

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

Treatment:

Drug: furosemide

ethacryinic acid

Active Comparator group

Description:

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

Treatment:

Drug: ethacrynic acid