Lipopolysaccharide Binding Protein and Development of Infectious Events in Cirrhotic Patients

Sponsor

Florencia Vargas-Vorackova (Other)

Overall Status

Withdrawn

CT.gov ID

NCT00760032

Collaborator

Laboratorios Senosiain, S.A. de C.V. (Industry)

Enrollment

Location

Arms

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cirrhosis Ascites Infections	Drug: Ciprofloxacin Drug: Placebo	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Care Provider)

Primary Purpose:

Diagnostic

Official Title:

Association of Serum Levels of Lipopolysaccharide Binding Protein (LBP) With the Evolution of Pro- and Anti-inflammatory Cytokines, and the Development of Severe Infectious Events in Cirrhotic Patients

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Active Ciprofloxacin	Drug: Ciprofloxacin Ciprofloxacin oral, 500 mg capsules, one capsule per day during four weeks. Other Names: Ciproflox
Placebo Comparator: Placebo Placebo	Drug: Placebo Placebo capsules, one capsule per day during four weeks.

Arm

Intervention/Treatment

Experimental: Active

Ciprofloxacin

Drug: Ciprofloxacin

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

Other Names:

Ciproflox

Placebo Comparator: Placebo

Placebo

Drug: Placebo

Placebo capsules, one capsule per day during four weeks.

Outcome Measures

Primary Outcome Measures

Lipopolysaccharide binding protein plasma levels [24 weeks]

Secondary Outcome Measures

Severe infection [24 weeks]
Pro- and anti-inflammatory cytokine secretion by PBMN cells [24 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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