Fluid Overload Clinical Trial
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
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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