Lipopolysaccharide Binding Protein and Development of Infectious Events in Cirrhotic Patients

This study has been withdrawn prior to enrollment.
(was not possible to measure LBP levels because we cannot found the kit)
Sponsor:
Collaborator:
Laboratorios Senosiain, S.A. de C.V.
Information provided by (Responsible Party):
Florencia Vargas-Vorackova, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
ClinicalTrials.gov Identifier:
NCT00760032
First received: September 24, 2008
Last updated: December 4, 2012
Last verified: December 2012
  Purpose

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 Intervention Phase
Cirrhosis
Ascites
Infections
Drug: Ciprofloxacin
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
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

Resource links provided by NLM:


Further study details as provided by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran:

Primary Outcome Measures:
  • Lipopolysaccharide binding protein plasma levels [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Severe infection [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Pro- and anti-inflammatory cytokine secretion by PBMN cells [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Enrollment: 0
Arms Assigned Interventions
Experimental: Active
Ciprofloxacin
Drug: Ciprofloxacin
Ciprofloxacin oral, 500 mg capsules, one capsule per day during four weeks.
Other Name: Ciproflox
Placebo Comparator: Placebo
Placebo
Drug: Placebo
Placebo capsules, one capsule per day during four weeks.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00760032

Locations
Mexico
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Mexico, D.f., Mexico, 14000
Sponsors and Collaborators
Florencia Vargas-Vorackova
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
  More Information

Additional Information:
No publications provided

Responsible Party: Florencia Vargas-Vorackova, Doctor, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
ClinicalTrials.gov Identifier: NCT00760032     History of Changes
Other Study ID Numbers: GAS-149-07-09-1, REF. 1612
Study First Received: September 24, 2008
Last Updated: December 4, 2012
Health Authority: Mexico: Ethics Committee

Keywords provided by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran:
Cirrhosis
Ascites
Lipopolysaccharide binding protein
Infections
Cytokines
Ciprofloxacin

Additional relevant MeSH terms:
Ascites
Liver Cirrhosis
Fibrosis
Pathologic Processes
Liver Diseases
Digestive System Diseases
Ciprofloxacin
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 24, 2014