Furosemide Versus Ethacrynic Acid in Children With Congenital Heart Disease

Bambino Gesù Hospital and Research Institute74 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Fluid Overload

Interventions

furosemideDRUG

furosemide, intravenous, continuous infusion, 0.2 mg/kg/h for 24 hours

ethacrynic acidDRUG

ethacrynic acid, intravenous, continuous infusion, 0.2 mg/kg/h for 24 hours

Eligibility

Sex: ALLMax age: 10 Years

Medical Language ↔ Plain English

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

Locations (1)

Bambino Gesù Hospital

Rome, Italy

Outcomes

Primary Outcomes

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

Time frame: first 24 hours after Intensive Care Unit admission

Secondary Outcomes

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

Time frame: first 72 hours after Intensive Care Unit admission

Data from ClinicalTrials.gov

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