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

Sun Yat-sen University

Status: Completed

Conditions: Hepatitis B, Chronic

Study type: Observational

Funder types: Other

Identifiers

NCT01107483

endotoxaemiaobservation

Details and patient eligibility

About

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).

Full 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.

Enrollment: 140 patients

Sex: All

Ages: 24 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

140 participants in 5 patient groups

AC group

Description:

asymptomatic carriers

CH group

Description:

patients with chronic hepatitis

HC group

Description:

patients with hepatic cirrhosis

ACLF group

Description:

patients with acute on chronic liver failure

healthy control

Description:

healthy volunteers