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

Primary Purpose

Severe Sepsis, Pancreatitis, Abdominal Abscess

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Norepinephrine
Open abdomen
enteral nutrition
parenteral nutrition
Sponsored by
Jinling Hospital, China
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional screening trial for Severe Sepsis

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Surgery, Jinling Hospital

Outcomes

Primary Outcome Measures

All cause mortality
Patients died within the first three days of admission would be excluded from this study.

Secondary Outcome Measures

Postoperative complications
wound complications; pulmonary infection; incisional hernia, and bleeding.

Full Information

First Posted
March 29, 2012
Last Updated
April 5, 2012
Sponsor
Jinling Hospital, China
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1. Study Identification

Unique Protocol Identification Number
NCT01568853
Brief Title
A Prospective Study of The Complement Depletion in Patients With Severe Abdominal Sepsis
Official Title
The Complement C3 Depletion in Patients With Severe Abdominal Sepsis: Risk Prediction and the Association With Down-regulated Adaptive Immunity
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jinling Hospital, China

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Sepsis, Pancreatitis, Abdominal Abscess, Appendicitis, Digestive System Fistula

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Norepinephrine
Intervention Description
Intravenously, 10 ug/min, 24 hours
Intervention Type
Procedure
Intervention Name(s)
Open abdomen
Intervention Description
IAH >=20 mmHg, and ACS emerged, such as low urine and decreased FiO2 quickly.
Intervention Type
Other
Intervention Name(s)
enteral nutrition
Other Intervention Name(s)
Peptison (SP; Nutricia, Shanghai, China)
Intervention Description
500-1500 kcal/day; Nasogastric tube feeding;
Intervention Type
Other
Intervention Name(s)
parenteral nutrition
Other Intervention Name(s)
Made by our hospital.
Intervention Description
3000 mL parenteral nutrition fluid, intravenously.
Primary Outcome Measure Information:
Title
All cause mortality
Description
Patients died within the first three days of admission would be excluded from this study.
Time Frame
within the first 28 days after admission to our hosptial
Secondary Outcome Measure Information:
Title
Postoperative complications
Description
wound complications; pulmonary infection; incisional hernia, and bleeding.
Time Frame
within the first 28 days after admission to our hosptial

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianan Ren, M.D.
Organizational Affiliation
Department of Surgery, Jinling Hospital, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Surgery, Jinling Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210002
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
23091606
Citation
Ren J, Zhao Y, Yuan Y, Han G, Li W, Huang Q, Tong Z, Li J. Complement depletion deteriorates clinical outcomes of severe abdominal sepsis: a conspirator of infection and coagulopathy in crime? PLoS One. 2012;7(10):e47095. doi: 10.1371/journal.pone.0047095. Epub 2012 Oct 16. Erratum In: PLoS One. 2013;8(3). doi:10.1371/annotation/45250927-10e7-4545-8fdf-066e688cc125.
Results Reference
derived

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

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