Furosemide Versus Ethacrynic Acid in Children With Congenital Heart Disease
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|ClinicalTrials.gov Identifier: NCT01628731|
Recruitment Status : Completed
First Posted : June 27, 2012
Last Update Posted : July 24, 2014
|Condition or disease||Intervention/treatment||Phase|
|Fluid Overload||Drug: furosemide Drug: ethacrynic acid||Phase 3|
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 (Clinical Trial)|
|Actual Enrollment :||74 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||October 2012|
|Actual Primary Completion Date :||July 2013|
|Actual Study Completion Date :||November 2013|
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
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01628731
|Bambino Gesù Hospital|
|Rome, Italy, 00165|
|Principal Investigator:||Zaccaria Ricci, MD||Bambino Gesù Hospital RI|