Albumin in acute-on-chronic liver failure: More than just volume?A randomized, controlled study - Albumin in ACLF

• Conditions: Spntaneous bacterial peritonitis; MedDRA version: 9.1Level: LLTClassification code 10001558Term: Albumin

• Registration Number: EUCTR2007-003769-41-AT
• Lead Sponsor: Medical University Graz

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08-17
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

•Patients with a clinical, radiological and/or histological evidence of cirrhosis and a polymorphonuclear-cell count in the ascitic fluid of more than 250 per cubic millimeter (spontaneous bacterial peritonitis, SBP)
•Age above 18

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years)
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•findings suggestive of secondary peritonitis
•antibiotic treatment within one week before the diagnosis of spontaneous bacterial peritonitis (except for prophylactic treatment with norfloxacin/levofloxacin)
•presence of infections other than spontaneous bacterial peritonitis
•gastrointestinal bleeding within last 14 days
•ileus
•shock, cardiac failure (inotrope requirement)
•hepatic encephalopathy grade >2
•findings suggestive of organic nephropathy or a serum creatinine level of no more than 150 µmol per liter
•human immunodeficiency virus infection
•any disease (e.g., advanced neoplasia) that could affect the short-term prognosis
•potential causes of dehydration (such as diarrhea or an intense response to diuretic treatment) within one week before the diagnosis of peritonitis.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified