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

Severe Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01568853
• Other study ID #: BK2010-017-1
• Status: Completed
• Phase: N/A
• First received: March 29, 2012
• Last updated: April 5, 2012
• Start date: November 2011
• Est. completion date: March 2012

Study information

• Verified date: April 2012
• Source: Jinling Hospital, China
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardChina: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Clinical diagnosis of severe abdominal sepsis

Exclusion Criteria:

• 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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Abdominal Abscess
• Appendicitis
• Digestive System Fistula
• Pancreatitis
• Sepsis
• Severe Sepsis

Intervention

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;
• parenteral nutrition
3000 mL parenteral nutrition fluid, intravenously.

Locations

Country	Name	City	State
China	Department of Surgery, Jinling Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Jinling Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All cause mortality	Patients died within the first three days of admission would be excluded from this study.	within the first 28 days after admission to our hosptial	No
Secondary	Postoperative complications	wound complications; pulmonary infection; incisional hernia, and bleeding.	within the first 28 days after admission to our hosptial	No