E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients undergoing cardiac surgery at risk for developing acute kidney injury |
Pazienti sottoposti a intervento di cardiochirurgia a rischio di sviluppare insufficienza renale acuta |
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E.1.1.1 | Medical condition in easily understood language |
Patients undergoing cardiac surgery at risk for developing acute kidney injury |
Pazienti sottoposti a intervento di cardiochirurgia a rischio di sviluppare insufficienza renale acuta |
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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 | 21.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10069339 |
E.1.2 | Term | Acute kidney injury |
E.1.2 | System Organ Class | 10038359 - Renal and urinary 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 |
reduce acute kidney injury incidence after cardiac surgery |
Ridurre l’incidenza dell’insufficienza renale acuta post cardiochirurgica |
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E.2.2 | Secondary objectives of the trial |
reduce the need and duration of renal replacement therapy, reduce hospital stay and admission to the ICU, reduce overall mortality. Reduce need and duration of mechanical ventilation. Improve quality of life |
Ridurre la necessità e la durata della terapia sostitutiva renale, ridurre i tempi di ricovero ospedaliero e in terapia intensiva, ridurre la mortalità generale. Ridurre la necessità e la durata della ventilazione meccanica. Migliorare la qualità di vita. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Aged 18 years; Scheduled cardiac surgery; Expected to stay in ICU at least one night after surgery; Signed informed consent
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18 anni di età, Intervento cardiochirurgico programmato, Aspettativa di passare almeno 1 notte in Terapia Intensiva dopo l’intervento, Consenso informato firmato
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E.4 | Principal exclusion criteria |
1. Patient currently enrolled into another randomized clinical trial;2. Patient currently receiving or scheduled for intermittent or continuous renal replacement therapy; 3. Patients with CKD of equal or more than CKD stage IV (GFR<30 ml/min/1.73 m2); 4. Patient with a kidney transplant: 5. Patient is not expected to survive ICU or hospital discharge; 6. Patient previously been enrolled and randomized into this study: 7. Patient has severe liver disease (Child-Pugh score >7 points); 8. Patient has a hypersensitivity (known allergy) to one or more of the included amino acids; 9. Patient has a congenital alteration of amino acid metabolism; 10. Pregnant or currently breastfeeding patients
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1. Paziente già arruolato in un altro trial clinico randomizzato; 2. Paziente che già riceve o ha in programma una terapia sostitutiva renale continua o intermittente; 3. Pazienti con insufficienza renale cronica (IRC) di stadio IV o superiore (GFR<30 mL/min/1.73m2); 4. Pazienti che hanno ricevuto un trapianto di rene; 5.Pazienti senza aspettativa di sopravvivere al ricovero in TI o in ospedale; 6. Pazienti già arruolati e randomizzati in questo studio; 7. Pazienti che abbiano un’insufficienza epatica severa (Child-Pugh score >7 punti); 8. Pazienti con ipersensibilità (allergia conosciuta) a uno o più degli aminoacidi inclusi; 9. Pazienti con alterazioni congenite del metabolismo degli aminoacidi; 10. Donne gravide o in allattamento
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E.5 End points |
E.5.1 | Primary end point(s) |
AKI during hospital stay defined by KDIGO stage 1 or greater (serum creatinine increase of at least 1.5 from baseline or >0.3 mg/dl or urine output <0.5 ml/kg/h for 6-12 hours). |
Aumento della creatinina sierica di almeno 1,5 volte rispetto al basale o >di 0,3 ml/dl o diuresi < a 0.5 ml/kg/h per 6-12 ore |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
During hospital stay |
Per tutto il tempo di ricovero |
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E.5.2 | Secondary end point(s) |
Need and duration of renal replacement therapy, ICU lenght of stay, duration of hospital stay, need and duration of mechanical ventilation, overall mortality, quality of life. |
Necessità e durata della terapia sostitutiva renale, durata del ricovero in terapia intensiva, durata del ricovero ospedaliero, necessità e durata della ventilazione meccanica, mortalità generale, qualità di vita. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
During hospital stay, and at 30, 90 and 180 days from randomization. |
Durante il ricovero ospedaliero, 30, 90 e 180 giorni dalla data di randomizzazione. |
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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 | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
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) | No |
E.8.2.2 | Placebo | Yes |
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 | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 17 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 18 |
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 | Information not present in EudraCT |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |