Lipopolysaccharide Binding Protein and Development of Infectious Events in Cirrhotic Patients

Florencia Vargas-Vorackova

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

DOUBLE

Conditions

Cirrhosis Ascites Infections

Interventions

CiprofloxacinDRUG

Ciprofloxacin oral, 500 mg capsules, one capsule per day during four weeks.

PlaceboDRUG

Placebo capsules, one capsule per day during four weeks.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

México, D.f., Mexico

Outcomes

Primary Outcomes

Lipopolysaccharide binding protein plasma levels

Time frame: 24 weeks

Secondary Outcomes

Severe infection

Time frame: 24 weeks

Pro- and anti-inflammatory cytokine secretion by PBMN cells

Time frame: 24 weeks

Data from ClinicalTrials.gov

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