Clinical trial NCT01107483: Observe Change of Endotoxaemia and Related Mediators in Patients With Chronic Hepatitis B Virus (HBV) Infection
Official title: Observe Change of Endotoxaemia and Related Mediators in Patients With Chronic HBV Infection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis B, Chronic
Keywords: endotoxaemia
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2010-04-21
Enrollment: 140
Sex: ALL
Minimum age (years): 24
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with chronic HBV infection admitted to The Third Affliated Hospital of 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.

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

Primary outcomes:
measure: plasma levels of endotoxin
timeFrame: 4 months
Secondary outcomes:
measure: serum albumin level
timeFrame: 4 months
measure: Plasma cytokine concentration
timeFrame: 4 months
measure: serum low density lipoprotein (LDL) level
timeFrame: 4 months
measure: serum high density lipoprotein (HDL) level
timeFrame: 4 months
measure: plasma sCD14 level
timeFrame: 4 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The Third Affliated Hospital of Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: The Third Affliated Hospital of Sun Yat-sen University
name: Gao Zhiliang, Professor
role: STUDY_CHAIR
References: