SE OF FENOLDOPAM TO IMPROVE GLOMERULAR FILTRATION RATE IN EARLY RENAL DYSFUNCTION AFTER LIVER TRANSPLANTATION - ND

Conditions: Adult liver transplanted patients age > 18 years , with pre-transplantation normal renal function creatinine clearance 1ml/kg/min
MedDRA version: 9.1Level: LLTClassification code 10038436Term: Renal failure acute

Registration Number: EUCTR2007-002109-32-IT

Lead Sponsor: AZIENDA SANITARIA OSPEDALIERA S. GIOVANNI BATTISTA DI TORINO

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

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

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 .

Secondary Outcome Measures