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

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

Official Title
-----------------
Observe Change of Endotoxaemia and Related Mediators in Patients With Chronic HBV Infection

Conditions
-----------------
Hepatitis B, Chronic

Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 24 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| AC group<br>asymptomatic carriers | |
| CH group<br>patients with chronic hepatitis | |
| HC group<br>patients with hepatic cirrhosis | |
| ACLF group<br>patients with acute on chronic liver failure | |
| healthy control<br>healthy volunteers | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| plasma levels of endotoxin |  | 4 months | 

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
endotoxaemia