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Lipopolysaccharide Binding Protein and Development of Infectious Events in Cirrhotic Patients

Primary Purpose

Cirrhosis, Ascites, Infections

Status

Withdrawn

Phase

Phase 4

Locations

Mexico

Study Type

Interventional

Intervention

Ciprofloxacin

Placebo

About this trial

This is an interventional diagnostic trial for Cirrhosis focused on measuring Cirrhosis, Ascites, Lipopolysaccharide binding protein, Infections, Cytokines, Ciprofloxacin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

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

Sites / Locations

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Active

Placebo

Arm Description

Ciprofloxacin

Placebo

Outcomes

Primary Outcome Measures

Lipopolysaccharide binding protein plasma levels

Secondary Outcome Measures

Severe infection

Pro- and anti-inflammatory cytokine secretion by PBMN cells

Full Information

NCT ID

NCT00760032

First Posted

September 24, 2008

Last Updated

December 4, 2012

Sponsor

Florencia Vargas-Vorackova

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT00760032

Brief Title

Lipopolysaccharide Binding Protein and Development of Infectious Events in Cirrhotic 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 Type

Interventional

2. Study Status

Record Verification Date

December 2012

Overall Recruitment Status

Withdrawn

Why Stopped

was not possible to measure LBP levels because we cannot found the kit

Study Start Date

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Primary Completion Date

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Study Completion Date

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3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Florencia Vargas-Vorackova

Collaborators

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

4. Oversight

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cirrhosis, Ascites, Infections

Keywords

Cirrhosis, Ascites, Lipopolysaccharide binding protein, Infections, Cytokines, Ciprofloxacin

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare Provider

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Active

Arm Type

Experimental

Arm Description

Ciprofloxacin

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo

Intervention Type

Drug

Intervention Name(s)

Ciprofloxacin

Other Intervention Name(s)

Ciproflox

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo capsules, one capsule per day during four weeks.

Primary Outcome Measure Information:

Title

Lipopolysaccharide binding protein plasma levels

Time Frame

24 weeks

Secondary Outcome Measure Information:

Title

Severe infection

Time Frame

24 weeks

Title

Pro- and anti-inflammatory cytokine secretion by PBMN cells

Time Frame

24 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Florencia Vargas-Vorackova, M.D., Ph.D.

Organizational Affiliation

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Official's Role

Principal Investigator

Facility Information:

Facility Name

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

City

Mexico

State/Province

D.f.

ZIP/Postal Code

14000

Country

Mexico

12. IPD Sharing Statement

Links:

URL

http://www.innsz.mx

Description

Sponsor's Web site

Learn more about this trial

Lipopolysaccharide Binding Protein and Development of Infectious Events in Cirrhotic Patients

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