Clinical trial NCT01628731: Furosemide Versus Ethacrynic Acid in Children With Congenital Heart Disease
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Fluid Overload
Keywords: loop diuretics
fluid balance
urine output
acute renal dysfunction
Lead sponsor: Bambino Gesù Hospital and Research Institute
Sponsor class: OTHER
First posted: 2012-06-27
Enrollment: 74
Sex: ALL
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Mean total urine output production in the first post-operative day
timeFrame: first 24 hours after Intensive Care Unit admission
Secondary outcomes:
measure: Mean creatinine and NGAL values
timeFrame: first 72 hours after Intensive Care Unit admission
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Bambino Gesù Hospital
Study officials:
affiliation: Bambino Gesù Hospital RI
name: Zaccaria Ricci, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Klinge JM, Scharf J, Hofbeck M, Gerling S, Bonakdar S, Singer H. Intermittent administration of furosemide versus continuous infusion in the postoperative management of children following open heart surgery. Intensive Care Med. 1997 Jun;23(6):693-7. doi: 10.1007/s001340050395.
citation: van der Vorst MM, Ruys-Dudok van Heel I, Kist-van Holthe JE, den Hartigh J, Schoemaker RC, Cohen AF, Burggraaf J. Continuous intravenous furosemide in haemodynamically unstable children after cardiac surgery. Intensive Care Med. 2001 Apr;27(4):711-5. doi: 10.1007/s001340000819.
citation: Bagshaw SM, Gibney RT, McAlister FA, Bellomo R. The SPARK Study: a phase II randomized blinded controlled trial of the effect of furosemide in critically ill patients with early acute kidney injury. Trials. 2010 May 11;11:50. doi: 10.1186/1745-6215-11-50.
citation: Ricci Z, Haiberger R, Pezzella C, Garisto C, Favia I, Cogo P. Furosemide versus ethacrynic acid in pediatric patients undergoing cardiac surgery: a randomized controlled trial. Crit Care. 2015 Jan 7;19(1):2. doi: 10.1186/s13054-014-0724-5.