Lipopolysaccharide Binding Protein and Development of Infectious Events in Cirrhotic Patients

December 4, 2012 updated by: Florencia Vargas-Vorackova

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

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 Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • D.f.
      • Mexico, D.f., Mexico, 14000
        • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Lipopolysaccharide binding protein plasma levels
Time Frame: 24 weeks
24 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Severe infection
Time Frame: 24 weeks
24 weeks
Pro- and anti-inflammatory cytokine secretion by PBMN cells
Time Frame: 24 weeks
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Florencia Vargas-Vorackova

Collaborators

Laboratorios Senosiain, S.A. de C.V.

Investigators

  • Principal Investigator: Florencia Vargas-Vorackova, M.D., Ph.D., Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

September 24, 2008

First Submitted That Met QC Criteria

September 24, 2008

First Posted (Estimate)

September 25, 2008

Study Record Updates

Last Update Posted (Estimate)

December 5, 2012

Last Update Submitted That Met QC Criteria

December 4, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GAS-149-07-09-1
  • REF. 1612

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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