Lipopolysaccharide Binding Protein and Development of Infectious Events in Cirrhotic Patients
- Registration Number
- NCT00760032
- Lead Sponsor
- Florencia Vargas-Vorackova
- Brief Summary
The purpose of this study is to determine whether plasma levels of lipopolysaccharide binding protein (LBP) are correlated with PBMN pro- and anti-inflammatory cytokine secretion, as well as with the development of severe infectious events in cirrhotic patients with ascites. As a secondary purpose, the study will evaluate the effect of a prophylactic administration of ciprofloxacin on LBP, cytokines and infections in the same patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- Cirrhosis
- Ascites
- No history of spontaneous bacterial peritonitis and/or < 1 g of protein in ascites
- No antibiotic use in previous 6 weeks
- Absence of infection (documented by clinical history, blood cytology, urinalysis and urine culture, thorax x-ray and paracentesis)
- Absence of GI bleeding or encephalopathy
- Signature of informed consent
Exclusion Criteria
- Ciprofloxacin contraindication
- Autoimmune hepatitis, sclerosing cholangitis or other autoimmune disease
- > 13 Child-Pugh points
- Inability to attend to regular visits
- Current alcohol intake
- Terminal disease with < 24 week expected survival
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo Active Ciprofloxacin Ciprofloxacin
- Primary Outcome Measures
Name Time Method Lipopolysaccharide binding protein plasma levels 24 weeks
- Secondary Outcome Measures
Name Time Method Severe infection 24 weeks Pro- and anti-inflammatory cytokine secretion by PBMN cells 24 weeks
Trial Locations
- Locations (1)
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
🇲🇽Mexico, D.f., Mexico
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran🇲🇽Mexico, D.f., Mexico