EFFECTIVENESS OF FUROSEMIDE IN CONTINUOUS INFUSION VS ethacrynic acid IN CONTINUOUS INFUSION IN CHILDREN SUBJECT TO A heart surgery of age LESS THAN 10 YEARS

STUDY PHASE III, RANDOMIZED, DOUBLE-BLIND CONTROLLED TO EVALUATE THE EFFECTIVENESS OF FUROSEMIDE IN CONTINUOUS INFUSION VS ethacrynic acid IN CONTINUOUS INFUSION IN CHILDREN SUBJECT TO A heart surgery of age LESS THAN 10 YEARS

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-004343-80-IT

Enrollment

100

Registered

2012-10-22

Start date

2012-09-20

Completion date

Unknown

Last updated

2014-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ALL CHILDREN AGE 'LESS THAN 10 YEARS OF AGE' WITH CONGENITAL HEART PROCEDURE SUBJECT TO cardiac surgery in whom the diuretic ARE GIVEN IN ACCORDANCE WITH THE FOLLOWING CONTINUOUS INFUSION PROTOCOL Cardiac surgery with clamping> 90 minutes Interventions interventional cardiology with hybrid approach and inotropic score> 20 after the procedure Capillary leak syndrome postoperative and / or signs of fluid overload MedDRA version: 14.1 Level: SOC Classification code 10007541 Term: Cardiac dis

Interventions

Pharmaceutical Form: Solution for infusion CAS Number: 54-31-9 Pharmaceutical Form: Solution for infusion CAS Number: 58-54-8

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: ALL CHILDREN AGE 'LESS THAN 10 YEARS OF AGE' WITH CONGENITAL HEART PROCEDURE SUBJECT TO cardiac surgery in whom the diuretic ARE GIVEN IN ACCORDANCE WITH THE FOLLOWING CONTINUOUS INFUSION PROTOCOL Cardiac surgery with clamping> 90 minutes Interventions interventional cardiology with hybrid approach and inotropic score> 20 after the procedure Capillary leak syndrome postoperative and / or signs of fluid overload Are the trial subjects under 18? yes Number of subjects for this age range: 100 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - PREOPERATIVE RENAL DYSFUNCTION - DIURETICS INFUSION OF HIGH-DOSE FOR EXTENDED PERIODS (more than one week) DURING PREOPERATIVE - NOTE A dialysis Extracorporeal ARRIVAL IN ICT - A STATEMENT IN PERITONEAL DIALYSIS PATIENTS IN ALL OLIGOANURICO 'ARRIVAL IN ICT - NOTE A Extracorporeal membrane oxygenation ARRIVAL IN ICT

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of our study will be: check whether there is a difference in urinary output of at least 1 ml / kg / h at the end of the 1st postoperative day (ie, the diuresis from the moment of ICT at the end of the 1st day , 6.00 am two mornings after surgery).;Secondary Objective: 1) Check the renal function in the two study groups by renal plasma biomarkers (creatinine, NGAL) and classification pRIFLE at the end of the first post-operative day. 2) Determination of biomarkers associated with signs of heart failure and reduced systemic perfusion (lactate, BNP, base excess) and inotropic score at the end of the first post-operative day to test the association between different diuretics and cardiac function.;Primary end point(s): - The primary objective of our study will be: check whether there is a difference in urinary output of at least 1 ml / kg / h at the end of the 1st postoperative day (ie, the diuresis from the moment of ICT at the end of the 1st day, 6.00 am two mornings after surgery).;Timepoint(s) of evaluation of this end point: cccc	—

Measure

Time frame

Main Objective: The primary objective of our study will be: check whether there is a difference in urinary output of at least 1 ml / kg / h at the end of the 1st postoperative day (ie, the diuresis from the moment of ICT at the end of the 1st day , 6.00 am two mornings after surgery).;Secondary Objective: 1) Check the renal function in the two study groups by renal plasma biomarkers (creatinine, NGAL) and classification pRIFLE at the end of the first post-operative day. 2) Determination of biomarkers associated with signs of heart failure and reduced systemic perfusion (lactate, BNP, base excess) and inotropic score at the end of the first post-operative day to test the association between different diuretics and cardiac function.;Primary end point(s): - The primary objective of our study will be: check whether there is a difference in urinary output of at least 1 ml / kg / h at the end of the 1st postoperative day (ie, the diuresis from the moment of ICT at the end of the 1st day, 6.00 am two mornings after surgery).;Timepoint(s) of evaluation of this end point: cccc

—

Secondary

Measure	Time frame
Secondary end point(s): cccc;Timepoint(s) of evaluation of this end point: ccc	—

Countries

Italy

Contacts

Public ContactCentro Trial

Ospedale Pediatrico Bambino Gesù

chiara.mennini@opbg.net0668592572

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026