A Prospective Study of The Complement Depletion in Patients With Severe Abdominal Sepsis

Sponsor

Jinling Hospital, China (Other)

Overall Status

Completed

CT.gov ID

NCT01568853

Collaborator

(none)

Enrollment

Location

Duration (Months)

18.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Severe Sepsis Pancreatitis Abdominal Abscess Appendicitis Digestive System Fistula	Drug: Norepinephrine Procedure: Open abdomen Other: enteral nutrition Other: parenteral nutrition	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

75 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Screening

Official Title:

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

Study Start Date :

Nov 1, 2011

Actual Primary Completion Date :

Mar 1, 2012

Actual Study Completion Date :

Mar 1, 2012

Outcome Measures

Primary Outcome Measures

All cause mortality [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.

Secondary Outcome Measures

Postoperative complications [within the first 28 days after admission to our hosptial]
wound complications; pulmonary infection; incisional hernia, and bleeding.