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Completed

NCT Number: NCT01628731

Furosemide Versus Ethacrynic Acid in Children With Congenital Heart Disease

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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Key information

Age range

Up to 10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Bambino Gesù Hospital

Rome, 00165, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Furosemide

Drug

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

Other names: lasix

Ethacrynic Acid

Drug

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

Other names: reomax

Primary outcomes

  1. Mean total urine output production in the first post-operative day

    Time frame: first 24 hours after Intensive Care Unit admission

    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

Secondary outcomes

  1. Mean creatinine and NGAL values

    Time frame: first 72 hours after Intensive Care Unit admission

    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

Sponsors and collaborators

Lead sponsor

Bambino Gesù Hospital and Research Institute

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jun 27, 2012
Registry last updated
Jul 24, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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