A Prospective Study of The Complement Depletion in Patients With Severe Abdominal Sepsis
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Purpose
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 | Intervention |
|---|---|
|
Severe Sepsis Pancreatitis Abdominal Abscess Appendicitis Digestive System Fistula |
Drug: Norepinephrine Procedure: Open abdomen Other: enteral nutrition Other: parenteral nutrition |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: 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 |
- All cause mortality [ Time Frame: within the first 28 days after admission to our hosptial ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]wound complications; pulmonary infection; incisional hernia, and bleeding.
| Enrollment: | 75 |
| Study Start Date: | November 2011 |
| Study Completion Date: | March 2012 |
| Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
-
Drug: Norepinephrine
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.
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts 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
Contacts and Locations| China, Jiangsu | |
| Department of Surgery, Jinling Hospital | |
| Nanjing, Jiangsu, China, 210002 | |
| Principal Investigator: | Jianan Ren, M.D. | Department of Surgery, Jinling Hospital, China |
More Information
No publications provided by Jinling Hospital, China
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Jianan Ren, Clinical professor, Principal investigator, Jinling Hospital, China |
| ClinicalTrials.gov Identifier: | NCT01568853 History of Changes |
| Other Study ID Numbers: | BK2010-017-1 |
| Study First Received: | March 29, 2012 |
| Last Updated: | April 5, 2012 |
| Health Authority: | United States: Institutional Review Board China: Food and Drug Administration |
Additional relevant MeSH terms:
|
Abscess Appendicitis Fistula Pancreatitis Sepsis Toxemia Digestive System Fistula Abdominal Abscess Suppuration Infection Inflammation Pathologic Processes Gastroenteritis Gastrointestinal Diseases Digestive System Diseases |
Cecal Diseases Intestinal Diseases Pathological Conditions, Anatomical Pancreatic Diseases Systemic Inflammatory Response Syndrome Norepinephrine Sympathomimetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Vasoconstrictor Agents Cardiovascular Agents Therapeutic Uses Adrenergic alpha-Agonists |
ClinicalTrials.gov processed this record on May 21, 2013