Spntaneous bacterial peritonitis MedDRA version: 9.1 Level: LLT Classification code 10001558 Term: Albumin
Conditions
Interventions
Trade Name: HUMANALBUMIN „BIOTEST“ 20% Infusionsflasche
Pharmaceutical Form: Intravenous infusion
Sponsors
Medical University Graz
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: We hypothesize that infusion of albumin can improve endotoxin binding capacity and thereby prevent inappropriate neutrophil activation and neutrophil dysfunction in patients with spontaneous bacterial peritonitis. Therefore we aim to investigate neutrophil function (oxidative burst) before, during and after high-dose albumin infusions as compared to standard therapy. ;Secondary Objective: 1) Increase in phagocytic capacity of neutrophils 2) Increase in endotoxin binding capacity 3) Improvement of albumin function and parameters of oxidative damage 4) Occurrence of the organ failure (one or more of the following) a. Hepatic Encephalopathy: Grade > 2 according to the West-Haven criteria. b. Renal Failure: Defined as an increase in serum creatinine level by more than 50 percent of the pretreatment value, to levels higher than 200umol/L. In patients with preexisting renal dysfunction (creatinine>100umol/L), an increase in serum creatinine level by more than 50 percent. c. Requirement of inotropic support to keep mean arterial pressure greater than 60 mmHg. 5) 3-month mortality 6) Length of hospital stay ;Primary end point(s): Decrease in resting oxidative burst of neutrophils | — |
Countries
Austria
Outcome results
None listed