Bambino Gesù Hospital
Rome, 00165, Italy
NCT Number: NCT01628731
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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Notify MeUp to 10 year
All sexes
Interventional
Phase 3
Rome, 00165, Italy
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
furosemide, intravenous, continuous infusion, 0.2 mg/kg/h for 24 hours
Other names: lasix
ethacrynic acid, intravenous, continuous infusion, 0.2 mg/kg/h for 24 hours
Other names: reomax
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
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
Bambino Gesù Hospital and Research Institute
Other
Phase III Study of Furosemide Continuous Infusion Versus Ethacrynic Acid Continuous Infusion in Children Undergoing Cardiac Surgery: Randomized Double Blind Controlled Clinical Trial
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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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