NCT01107483已完成不适用
Observe Change of Endotoxaemia and Related Mediators in Patients With Chronic HBV Infection
Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2009年12月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- plasma levels of endotoxin
研究概览
简要总结
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).
详细描述
- 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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 24 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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).
排除标准
- •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
结局指标
主要结局
plasma levels of endotoxin
时间窗: 4 months
次要结局
- serum albumin level(4 months)
- Plasma cytokine concentration(4 months)
- serum low density lipoprotein (LDL) level(4 months)
- serum high density lipoprotein (HDL) level(4 months)
- plasma sCD14 level(4 months)
研究者
研究点 (1)
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