Lipopolysaccharide Binding Protein and Development of Infectious Events in Cirrhotic Patients

Condition(s) targeted: Cirrhosis; Ascites; Infections

Intervention: Ciprofloxacin (Drug); Placebo (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Official(s) and/or principal investigator(s):
Florencia Vargas-Vorackova, M.D., Ph.D., Principal Investigator, Affiliation: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Overall contact:
Felix I Tellez-Avila, M.D., M.Sc., Phone: (5255)5573-3418, Email: felixtelleza@gmail.com

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.

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Diagnostic

Primary outcome: Lipopolysaccharide binding protein plasma levels

Secondary outcome:

Severe infection

Pro- and anti-inflammatory cytokine secretion by PBMN cells

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Felix I Tellez-Avila, M.D., M.Sc., Phone: (5255)5573-3418, Email: felixtelleza@gmail.com

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran, Mexico, D.f. 14000, Mexico; Recruiting
Email: florvar@quetzal.innsz.mx
Florencia Vargas-Vorackova, M.D., Ph.D., Principal Investigator
Felix I Tellez-Avila, M.D., M.Sc., Sub-Investigator
Ada M Franco-Guzman, M.D., Sub-Investigator
Roberto Ruiz-Cordero, M.D., Sub-Investigator
Jose Sifuentes-Osornio, M.D., Sub-Investigator

Sponsor's Web site

Starting date: August 2006
Last updated: September 24, 2008