Status:
COMPLETED
Norfloxacin In The Primary Prophylaxis Of Spontaneous Bacterial Peritonitis
Lead Sponsor:
Hospital Clinic of Barcelona
Conditions:
Spontaneous Bacterial Peritonitis
Hepatorenal Syndrome
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
Advanced liver disease and low ascitic fluid protein concentration have been identified as risk factors for spontaneous bacterial peritonitis in cirrhosis. Moreover, renal impairment and hyponatremia ...
Eligibility Criteria
Inclusion
- Age 18-80 years, protein concentration in ascitic fluid \< 15 g/L and at least one of the following: serum creatinine ≥ 1.2 mg/dl or BUN ≥ 25 mg/dl, serum sodium ≤ 130 mEq/L or severe liver failure as defined by a Child-Pugh score ≥ 9 points and a serum bilirubin ≥ 3 mg/dl.
Exclusion
- Previous history of spontaneous bacterial peritonitis or of norfloxacin prophylaxis, allergy to quinolones, hepatocellular carcinoma, organic renal failure and HIV infection
Key Trial Info
Start Date :
September 1 2000
Trial Type :
INTERVENTIONAL
End Date :
March 1 2005
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT00359853
Start Date
September 1 2000
End Date
March 1 2005
Last Update
August 3 2006
Active Locations (1)
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1
Hospital Clinic Barcelona
Barcelona, Catalonia, Spain, 08036