Trial | NCT00760032  Report issue

Title

Lipopolysaccharide Binding Protein and Development of Infectious Events in Cirrhotic Patients
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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Withdrawn

  • Study Participants

    0
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 Started
Sep 24
2008
Last Update
Dec 05
2012
Estimate

Drug Ciprofloxacin

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

  • Other names: Ciproflox

Drug Placebo

Placebo capsules, one capsule per day during four weeks.

Active Experimental

Ciprofloxacin

Placebo Placebo Comparator

Placebo

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
No Results Posted