Furosemide Versus Ethacrynic Acid in Children With Congenital Heart Disease

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Fluid Overload

Intervention / Treatment
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* Drug: furosemide
* Drug: ethacrynic acid


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: furosemide<br>furosemide, 0.2 mg/kg/h up to 0.8 mg/kg/h for 72 hours | Drug: furosemide<br>* furosemide, intravenous, continuous infusion, 0.2 mg/kg/h for 24 hours<br>* Other names: lasix;|
| Active Comparator: ethacryinic acid<br>ethacrynic acid, 0.2 mg/kg/h up to 0.8 mg/kg/h for 72 hours | Drug: ethacrynic acid<br>* ethacrynic acid, intravenous, continuous infusion, 0.2 mg/kg/h for 24 hours<br>* Other names: reomax;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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loop diuretics, fluid balance, urine output, acute renal dysfunction