E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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 |
TUTTI I BAMBINI DI ETA’ INFERIORE A 10 ANNI DI ETA’ CON CARDIOPATIA CONGENITA SOTTOPOSTI A PROCEDURA CARDIOCHIRURGICA IN CUI IL DIURETICO SIA SOMMINISTRATO IN INFUSIONE CONTINUA SECONDO IL SEGUENTE PROTOCOLLO Interventi cardiochirurgici con clampaggio >90 minuti Interventi di cardiologia interventistica con approccio ibrido e inotropic score > 20 dopo la procedura Capillary leak syndrome postoperatoria e/o segni di sovraccarico idrico |
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E.1.1.1 | Medical condition in easily understood language |
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 P |
TUTTI I BAMBINI DI ETA’ INFERIORE A 10 ANNI DI ETA’ CON CARDIOPATIA CONGENITA SOTTOPOSTI A PROCEDURA CARDIOCHIRURGICA IN CUI IL DIURETICO SIA SOMMINISTRATO IN INFUSIONE CONTINUA SECONDO IL |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cardiovascular Diseases [C14] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | SOC |
E.1.2 | Classification code | 10007541 |
E.1.2 | Term | Cardiac disorders |
E.1.2 | System Organ Class | 10007541 - Cardiac disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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). |
Obiettivo primario del nostro studio sarà: verificare se è presente una differenza di output urinario di almeno 1 ml/kg/h al termine della 1° giornata post-operatoria (cioè la diuresi dal momento dell’accettazione in TIC alla conclusione della 1° giornata, ore 6.00 di due mattine dopo l’intervento). |
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E.2.2 | Secondary objectives of the trial |
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. |
1)Verificare la funzionalità renale nei due gruppi di studio mediante biomarkers renali plasmatici (creatinina, NGAL) e classificazione pRIFLE al termine dalla prima giornata post-operatoria. 2)Dosaggio di biomarkers associati con segni di scompenso cardiaco e ridotta perfusione sistemica (lattatemia, BNP, eccesso base) e inotropic score al termine dalla prima giornata post-operatoria per verificare l’associazione tra differenti diuretici e funzionalità cardiaca. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 |
TUTTI I BAMBINI DI ETA’ INFERIORE A 10 ANNI DI ETA’ CON CARDIOPATIA CONGENITA SOTTOPOSTI A PROCEDURA CARDIOCHIRURGICA IN CUI IL DIURETICO SIA SOMMINISTRATO IN INFUSIONE CONTINUA SECONDO IL SEGUENTE PROTOCOLLO Interventi cardiochirurgici con clampaggio >90 minuti Interventi di cardiologia interventistica con approccio ibrido e inotropic score > 20 dopo la procedura Capillary leak syndrome postoperatoria e/o segni di sovraccarico idrico |
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E.4 | Principal 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 |
- DISFUNZIONE RENALE PREOPERATORIA - INFUSIONE DI DIURETICI AD ALTE DOSI PER PERIODI PROLUNGATI (superiori ad una settimana) NEL PERIODO PREOPERATORIO - INDICAZIONE A TERAPIA DIALITICA EXTRACOPOREA ALL’ARRIVO IN TIC - INDICAZIONE A DIALISI PERITONEALE NELLA IN PAZIENTE OLIGOANURICO ALL’ ARRIVO IN TIC - INDICAZIONE A EXTRACORPOREAL MEMBRANE OXYGENATION ALL’ARRIVO IN TIC |
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E.5 End points |
E.5.1 | 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). |
Obiettivo primario del nostro studio sarà: verificare se è presente una differenza di output urinario di almeno 1 ml/kg/h al termine della 1° giornata post-operatoria (cioè la diuresi dal momento dell’accettazione in TIC alla conclusione della 1° giornata, ore 6.00 di due mattine dopo l’intervento). |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Il soggetto sarà impegnato nella sperimentazione nel corso delle giornate post-operatorie 0 e 1. I dati saranno raccolti anche in giornata 2, con un follow up sui dati di outcome (v.sopra) fino alla dimissione da TIC. Lo studio è previsto per una durata di 1 anno. |
Il soggetto sarà impegnato nella sperimentazione nel corso delle giornate post-operatorie 0 e 1. I dati saranno raccolti anche in giornata 2, con un follow up sui dati di outcome (v.sopra) fino alla dimissione da TIC. Lo studio è previsto per una du |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 12 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 12 |
E.8.9.2 | In all countries concerned by the trial days | 0 |