Observe Change of Endotoxaemia and Related Mediators in Patients With Chronic Hepatitis B Virus (HBV) Infection

NCT ID: NCT01107483

Last Updated: 2010-05-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 140 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-12-31
• Study Completion Date: 2010-03-31

Brief Summary

This study was designed for changes in endotoxaemia, endotoxin-binding factors, sICAM-1 (soluble intracellular adhesion molecule-1), and cytokines during progression of chronic HBV infection. Patients with chronic HBV infection and healthy control are included. A limulus assay was used to measure plasma endotoxin level and ELISAs were used to measure the concentrations of interleukin-6 (IL-6), interleukin-10 (IL-10), tumor necrosis factor-α (TNFα), sICAM-1, and soluble CD14 (sCD14).

Detailed Description

1. Patients Patients with chronic HBV infection and healthy volunteers were enrolled. There were asymptomatic carriers group, patients with chronic hepatitis, patients with hepatic cirrhosis, and patients with acute on chronic liver failure.

2. Endotoxin assay Blood samples were obtained under aseptic conditions by peripheral venipuncture and using pyrogen-free syringes, needles, and glassware. Plasma samples were heated at 70℃ for 10 min. Plasma concentration was then measured in duplicate using a commercially available Limulus amebocyte lysate assay following the manufacturer's protocol.

3. ELISA ELISA kits were used to assess in duplicate the plasma concentrations of IL-6, IL-10, TNFα, sICAM-1 and sCD14.

Conditions

Hepatitis B, Chronic

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

AC group

asymptomatic carriers

No interventions assigned to this group

CH group

patients with chronic hepatitis

No interventions assigned to this group

HC group

patients with hepatic cirrhosis

No interventions assigned to this group

ACLF group

patients with acute on chronic liver failure

No interventions assigned to this group

healthy control

healthy volunteers

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Chronic HBV infection
• Diagnosis confirm to guideline of Chronic Hepatitis B and acute on chronic liver failure of the Asian Pacific Association for the Study of the Liver (APASL).

Exclusion Criteria

• All the patients had no obvious mycotic infection, Gram-negative sepsis, or bacterial infection (except from the digestive system)
• Infection of hepatitis A, C, D, or E virus
• Autoimmune liver disease
• Alcoholic liver disease
• Metabolic liver disease
• Drug-induced liver injury
• Parasitic disease of the hepatobiliary system
• Malignancy
• Serious exacerbation of cardiovascular and respiratory system diseases

• Minimum Eligible Age: 24 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

The Third Affliated Hospital of Sun Yat-sen University

Principal Investigators

Gao Zhiliang, Professor

Role: STUDY_CHAIR

The Third Affliated Hospital of Sun Yat-sen University

Locations

The Third Affliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

endotoxaemiaobservation

Identifier Type: -

Identifier Source: org_study_id