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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01568853
Enrollment
75
Registered
2012-04-02
Start date
2011-11-30
Completion date
2012-03-31
Last updated
2012-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

DRUGNorepinephrine

Intravenously, 10 ug/min, 24 hours

PROCEDUREOpen abdomen

IAH \>=20 mmHg, and ACS emerged, such as low urine and decreased FiO2 quickly.

OTHERenteral nutrition

500-1500 kcal/day; Nasogastric tube feeding;

OTHERparenteral nutrition

3000 mL parenteral nutrition fluid, intravenously.

Sponsors

Jinling Hospital, China
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
All cause mortalitywithin the first 28 days after admission to our hosptialPatients died within the first three days of admission would be excluded from this study.

Secondary

MeasureTime frameDescription
Postoperative complicationswithin the first 28 days after admission to our hosptialwound complications; pulmonary infection; incisional hernia, and bleeding.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 25, 2026