Lipopolysaccharide Binding Protein and Development of Infectious Events in Cirrhotic Patients

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Florencia Vargas-Vorackova
• Collaborator: Laboratorios Senosiain, S.A. de C.V.
• Treatments: Ciprofloxacin

Criteria

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