A Prospective Study of The Complement Depletion in Patients With Severe Abdominal Sepsis
|ClinicalTrials.gov Identifier: NCT01568853|
Recruitment Status : Completed
First Posted : April 2, 2012
Last Update Posted : April 6, 2012
|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||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||75 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 :||November 2011|
|Actual Primary Completion Date :||March 2012|
|Actual Study Completion Date :||March 2012|
- Drug: Norepinephrine
Intravenously, 10 ug/min, 24 hours
- Procedure: Open abdomen
IAH >=20 mmHg, and ACS emerged, such as low urine and decreased FiO2 quickly.
- Other: enteral nutrition
500-1500 kcal/day; Nasogastric tube feeding;Other Name: Peptison (SP; Nutricia, Shanghai, China)
- Other: parenteral nutrition
3000 mL parenteral nutrition fluid, intravenously.Other Name: Made by our hospital.
- All cause mortality [ Time Frame: 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.
- Postoperative complications [ Time Frame: within the first 28 days after admission to our hosptial ]wound complications; pulmonary infection; incisional hernia, and bleeding.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01568853
|Department of Surgery, Jinling Hospital|
|Nanjing, Jiangsu, China, 210002|
|Principal Investigator:||Jianan Ren, M.D.||Department of Surgery, Jinling Hospital, China|