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

Completed

• Conditions: Hepatitis B, Chronic

• Registration Number: NCT01107483
• Lead Sponsor: Sun Yat-sen University

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.

Study Timeline

• Study Start: 2009-12
• Status Verified: 2010-01
• Primary Completion: 2010-02
• Study Completion: 2010-03
• Study First Submitted: 2010-04-16
• Study First Submitted QC: 2010-04-19
• Study First Posted: 2010-04-21
• Last Update Submitted: 2010-05-06
• Last Update Posted: 2010-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
plasma levels of endotoxin	4 months

Secondary Outcome Measures

Name	Time	Method
serum albumin level	4 months
Plasma cytokine concentration	4 months	ELISA kits were used to assess in duplicate the plasma concentrations of IL-6, IL-10, TNFα, and sICAM-1 (Bender, Vienna, Austria).
serum low density lipoprotein (LDL) level	4 months
serum high density lipoprotein (HDL) level	4 months
plasma sCD14 level	4 months	ELISA kits were used to assess in duplicate the plasma concentrations of soluble CD14 (sCD14) (R\&D Systems, Minneapolis, MN).

Trial Locations

Locations (1)

The Third Affliated Hospital of Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China