E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Renal failure from ipoperfusion post Cardiac surgery |
Insufficienza renale da ipoperfusione post intervento Cardiochirurgico |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10000821 |
E.1.2 | Term | Acute kidney failure |
E.1.2 | System Organ Class | 10038359 - Renal and urinary disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10048988 |
E.1.2 | Term | Renal artery occlusion |
E.1.2 | System Organ Class | 10038359 - Renal and urinary disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10002482 |
E.1.2 | Term | Angiosclerosis |
E.1.2 | System Organ Class | 10047065 - Vascular 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 purpose of this study is to demonstrate that an infusion of fenoldopam for 96 hours is able to improve the outcome of renal patients undergoing intervention cardiochirurgico. In patients who have a screzio postoperative renal defined as ''R score of the RIFLE (increase in creatinine of 50% compared to preoperatorio cardiochirurgico diuresis or with a less than 0.5 ml / kg / h for 6 hours) will be evaluated the need renal replacement treatment (dialysis) during the stay in intensive care. In intensive therapy is used usually CVVH (continuous venous venous hemofiltration), which allows non-compromising hemodynamic stability of critical patients. End main point: Prevention positioning renal replacement treatment (CVVH or similar) to claim second and clinical protocols that exist in various departments |
Lo scopo di questo studio e' quello di dimostrare che uninfusione di fenoldopam per 96 ore e' in grado di migliorare loutcome renale di pazienti sottoposti ad intervento cardiochirurgico. In malati che hanno uno screzio renale postoperatorio definito come R dello score di RIFLE (aumento della creatininemia del 50% rispetto al preoperatorio cardiochirurgico oppure con una diuresi inferiore a 0,5 ml/kg/h per 6 ore) verra' valutata la necessita' di trattamento sostitutivo renale (dialisi) durante la degenza in terapia intensiva. Nelle terapie intensive si utilizza solitamente la CVVH (continuous venous venous hemofiltration) che permette di non compromettere la stabilita' emodinamica di malati critici. End point principale: Prevenzione del posizionamento di trattamento sostitutivo renale (CVVH o simile) a seconda dellindicazione clinica e dei protocolli esistenti nei vari reparti |
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E.2.2 | Secondary objectives of the trial |
End point secondary: -- Hospital mortality -- Mortality at 30 days -- Mortality to 1 years -- Times of mechanical ventilation -- Stay in intensive care -- Hospitalisation post intervention cardiochirurgico -- Peak creatinine (value and the time of achievement) -- Doubling of creatinine (value and the time of achievement) -- Tripling of creatinine (value and the time of achievement) -- I, M, L, E to the score of RIFLE |
End point secondari: --mortalita' ospedaliera --mortalita' a 30 giorni --mortalita' ad 1 anno --tempi di ventilazione meccanica --degenza in terapia intensiva --ospedalizzazione post intervento cardiochirurgico --picco di creatininemia (valore e momento del raggiungimento) --raddoppio della creatininemia (valore e momento del raggiungimento) --triplicare della creatininemia (valore e momento del raggiungimento) --I, F, L, E dello score di RIFLE |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Sick undergo intervention cardiochirurgico who develop at any time during the postoperative hospital in Intensive Care, a screzio renal defined as ''R'' of the score of RIFLE (increase in creatinine of 50% compared to preoperatorio cardiochirurgico diuresis or with a less than 0 , 5 ml / kg / h for 6 hours) and a planned hospital in cardiac intensive care exceeding 24 hours). The upside of creatinine can happen at any time of hospitalization in Intensive Care (not necessarily in the first 24-48 hours) for any reason (low flow, sepsis ..). |
Malati sottoposti ad intervento cardiochirurgico che sviluppano, in un qualsiasi momento durante il ricovero postoperatorio in Terapia Intensiva, uno screzio renale definito come R dello score di RIFLE (aumento della creatininemia del 50% rispetto al preoperatorio cardiochirurgico oppure con una diuresi inferiore a 0,5 ml/kg/h per 6 ore) e una degenza prevista in terapia intensiva cardiochirurgia superiore a 24 ore). Il rialzo della creatininemia puo' avvenire in un qualsiasi momento del ricovero in Terapia Intensiva (non necessariamente nelle prime 24-48 ore) e per qualsiasi motivo (bassa portata, sepsi..). |
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E.4 | Principal exclusion criteria |
-- Glaucoma -- Provided by the hospital intensive care within 24 hours -- Already taken the decision to place renal replacement treatment -- Already taken the decision not to therapeutic likely exitus -- Inclusion in other protocols randomized -- Age <18 years -- Lack of informed consent -- Patients who received fenoldopam in the previous 30 days -- Preoperative dialysis (temporary or permanent) |
--glaucoma --prevista dimissione dalla terapia intensiva entro 24 ore --gia' presa la decisione di posizionare trattamento sostitutivo renale --gia' presa la decisione di non accanimento terapeutico per probabile exitus --inclusione in altri protocolli randomizzati --eta' < 18 anni --mancanza di consenso informato --malati che hanno ricevuto fenoldopam nei 30 giorni precedenti --dialisi preoperatoria (temporanea o permanente) |
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E.5 End points |
E.5.1 | Primary end point(s) |
Prevention positioning renal replacement treatment (CVVH or similar) to claim second and clinical protocols that exist in various departments |
Prevenzione del posizionamento di trattamento sostitutivo renale (CVVH o simile) a seconda dellindicazione clinica e dei protocolli esistenti nei vari reparti |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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 | Yes |
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.8.3 |
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 | 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 | Yes |
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 | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |