Adult liver transplanted patients age > 18 years , with pre-transplantation normal renal function creatinine clearance 1ml/kg/min MedDRA version: 9.1 Level: LLT Classification code 10038436 Term: Renal failure acute
Conditions
Interventions
Trade Name: CORLOPAM 1F 2ML 20MG/2ML
Pharmaceutical Form: Solution for infusion
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-
Sponsors
AZIENDA SANITARIA OSPEDALIERA S. GIOVANNI BATTISTA DI TORINO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: adult liver transplanted patients age > 18 years , with pre-transplantation normal renal function creatinine clearance > 1ml/kg/min , characterized in the first week after liver transplantation by increase of serum creatinine more than 1,5 times compared to pre-operative value or urine out-put reduction 0,5 ml/kg/h for over 6 hours period without loop diuretics administration and after cardiovascular performance optimization hemodynamic stability defined as stable values of systemic systolic blood pressure 100 mmHg over the 6-hr period immediately preceding the enrollment low doses of vasopressor drugs are allowed . Are the trial subjects under 18? no Number of subjects for this age range: 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: life expectancy > 48 hrs renal dysfunction requiring renal replacement therapies hemodynamic instability sepsis urgent surgery need during the study administration of loop diuretic drugs furosemide 250 mg/24 hrs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to evaluate, in patients with early renal dysfunction after liver transplantation, the efficacy of fenoldopam mesylate in preserving/improving renal function glomerular filtration rate .;Secondary Objective: to evaluate if cystatin-C can be a reliable marker of glomerular filtration GFR changes in critically ill patient to evaluate if cystatin-C level may detect the changes in renal function due to vasoactive drugs as fenoldopam;Primary end point(s): to evaluate, in patients with early renal dysfunction after liver transplantation, the efficacy of fenoldopam mesylate in preserving/improving renal function glomerular filtration rate . | — |
Countries
Italy
Outcome results
None listed