Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| OBG DIURETICS | Other Identifier | Bambino Gesù Hospital RI |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| furosemide | Active Comparator | furosemide, 0.2 mg/kg/h up to 0.8 mg/kg/h for 72 hours |
|
| ethacryinic acid | Active Comparator | ethacrynic acid, 0.2 mg/kg/h up to 0.8 mg/kg/h for 72 hours |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| furosemide | Drug | furosemide, intravenous, continuous infusion, 0.2 mg/kg/h for 24 hours |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean total urine output production in the first post-operative day | 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 | first 24 hours after Intensive Care Unit admission |
| Measure | Description | Time Frame |
|---|---|---|
| Mean creatinine and NGAL values | 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 | first 72 hours after Intensive Care Unit admission |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Zaccaria Ricci, MD | Bambino Gesù Hospital RI | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bambino Gesù Hospital | Rome | 00165 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9255651 | Background | 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. | |
| 11398698 | Background | 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D004487 | Edema |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D005665 | Furosemide |
| D004976 | Ethacrynic Acid |
| ID | Term |
|---|---|
| D013424 | Sulfanilamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ethacrynic acid | Drug | ethacrynic acid, intravenous, continuous infusion, 0.2 mg/kg/h for 24 hours |
|
|
| 20459801 | Background | 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. |
| 25563826 | Derived | 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. |
| D000814 |
| Aniline Compounds |
| D000588 | Amines |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D010642 | Phenoxyacetates |
| D006016 | Glycolates |
| D000085 | Acetates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D006880 | Hydroxy Acids |