Furosemide Versus Ethacrynic Acid in Children With Congenital Heart Disease
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Phase III Study of Furosemide Continuous Infusion Versus Ethacrynic Acid Continuous Infusion in Children Undergoing Cardiac Surgery: Randomized Double Blind Controlled Clinical Trial|
- Mean total urine output production in the first post-operative day [ Time Frame: first 24 hours after Intensive Care Unit admission ] [ Designated as safety issue: No ]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
- Mean creatinine and NGAL values [ Time Frame: first 72 hours after Intensive Care Unit admission ] [ Designated as safety issue: No ]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
|Study Start Date:||October 2012|
|Study Completion Date:||November 2013|
|Primary Completion Date:||July 2013 (Final data collection date for primary outcome measure)|
Active Comparator: furosemide
furosemide, 0.2 mg/kg/h up to 0.8 mg/kg/h for 72 hours
furosemide, intravenous, continuous infusion, 0.2 mg/kg/h for 24 hours
Other Name: lasix
Active Comparator: ethacryinic acid
ethacrynic acid, 0.2 mg/kg/h up to 0.8 mg/kg/h for 72 hours
Drug: ethacrynic acid
ethacrynic acid, intravenous, continuous infusion, 0.2 mg/kg/h for 24 hours
Other Name: reomax
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01628731
|Bambino Gesù Hospital|
|Rome, Italy, 00165|
|Principal Investigator:||Zaccaria Ricci, MD||Bambino Gesù Hospital RI|