Renal failure from ipoperfusion post Cardiac surgery MedDRA version: 14.1 Level: LLT Classification code 10000821 Term: Acute kidney failure System Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 14.1 Level: PT Classification code 10048988 Term: Renal artery occlusion System Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 14.1 Level: PT Classification code 10002482 Term: Angiosclerosis System Organ Class: 10047065 - Vascular disorders
Conditions
Interventions
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Fenoldopam
Concentration unit: mg milligram(s)
Concentration number: 26.28-
Pharmaceutical form of the placebo: Solution for infusion
Ro
Sponsors
AZIENDA OSPEDALIERA DI PERUGIA
Eligibility
Sex/Gender
All
Inclusion criteria
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 ..). Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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;Secondary Objective: 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;Primary end point(s): Prevention positioning renal replacement treatment (CVVH or similar) to claim second and clinical protocols that exist in various departments | — |
Countries
Italy
Outcome results
None listed