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临床试验/NCT01568853
NCT01568853已完成不适用

The Complement C3 Depletion in Patients With Severe Abdominal Sepsis: Risk Prediction and the Association With Down-regulated Adaptive Immunity

Jinling Hospital, China1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2011年11月1日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
75
试验地点
1
主要终点
All cause mortality

研究概览

简要总结

The role of complement system in bridging innate and adaptive immunity has been confirmed in various invasive pathogens. The aim of this study is to investigate the alteration of complement C3 in patients with severe abdominal sepsis and evaluate the role of complement C3 depletion in prognosis of such patients. The relationship between complement C3 depletion and adaptive immunity is studied meanwhile.

详细描述

Severe abdominal sepsis remains a significant cause of death in patients undergoing intra-abdominal infection, in despite of recent declines in overall mortality. There is a abundant evidence to suggest complement activation during sepsis. While there is great interest in complement by-products in human sepsis, few studies focus on the persistent consumption of complement components and its role in prognosis of sepsis. Complement C3 is indispensable community pathway for complement activation. In a way, the alteration of C3 levels can affect the whole status of complement biological functions.

In clinical practice, the severe abdominal sepsis would develop compromised immune function if the intra-abdominal infection is not well controlled. The down-regulated T- and B-cell immune responses to sepsis are correlated to the decreased immune defense. To our knowledge, there are few human data that have investigated the relationship between complement depletion and adaptive immunity in severe abdominal sepsis. The investigators hypothesize that the complement C3 depletion during sepsis has a stronger association with the down-regulated adaptive immunity and can be regarded as a essential risk factor to predict the prognosis of such critical illness.

The purpose of this prospective study is two-fold. First, the investigators observe, in a cohort of patients with severe abdominal sepsis, the levels of complement components and percentages of T cell subsets after admission to evaluate the relationship between complement system and adaptive immunity. Second, the investigators also evaluate the application of the C3 related-indexes (C3, C3a, Factor H, DAF, etc.) to patients undergoing severe abdominal sepsis and to develop an alternative model to predict its prognosis.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Screening
盲法
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis of severe abdominal sepsis

排除标准

  • Age < 18 or > 60 years
  • Pregnancy
  • Leucopenia from radiochemical therapy due to malignant tumor
  • Any primary diagnosis other than sepsis
  • Confirmed immunodeficiency
  • Requirement for blood transfusion, plasmapheresis, or immediate surgery

结局指标

主要结局

All cause mortality

时间窗: within the first 28 days after admission to our hosptial

Patients died within the first three days of admission would be excluded from this study.

次要结局

  • Postoperative complications(within the first 28 days after admission to our hosptial)

研究者

发起方
Jinling Hospital, China
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jianan Ren

Clinical professor, Principal investigator

Jinling Hospital, China

研究点 (1)

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