Ignite Creation Date:
2024-05-06 @ 12:24 AM
Last Modification Date:
2024-10-26 @ 10:49 AM
Study NCT ID:
NCT01568853
Status:
COMPLETED
Last Update Posted:
2012-04-06
First Post:
2012-03-29
Brief Title:
A Prospective Study of The Complement Depletion in Patients With Severe Abdominal Sepsis
Sponsor:
Jinling Hospital China
Organization:
Jinling Hospital China
Study Overview
Official Title:
The Complement C3 Depletion in Patients With Severe Abdominal Sepsis Risk Prediction and the Association With Down-regulated Adaptive Immunity
Status:
COMPLETED
Status Verified Date:
2012-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None