Furosemide Versus Ethacrynic Acid in Children With Congenital Heart Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2013-11-30

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.

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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.

Conditions

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Fluid Overload

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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furosemide

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

Group Type ACTIVE_COMPARATOR

furosemide

Intervention Type DRUG

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

ethacryinic acid

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

Group Type ACTIVE_COMPARATOR

ethacrynic acid

Intervention Type DRUG

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

Interventions

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furosemide

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

Intervention Type DRUG

ethacrynic acid

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

Intervention Type DRUG

Other Intervention Names

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lasix reomax

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

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No