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

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ClinicalTrials.gov Identifier: NCT01568853
Recruitment Status : Completed
First Posted : April 2, 2012
Last Update Posted : April 6, 2012
Sponsor:
Information provided by (Responsible Party):
Jianan Ren, Jinling Hospital, China

Tracking Information
First Submitted Date  ICMJE March 29, 2012
First Posted Date  ICMJE April 2, 2012
Last Update Posted Date April 6, 2012
Study Start Date  ICMJE November 2011
Actual Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 30, 2012)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 30, 2012)
Postoperative complications [ Time Frame: within the first 28 days after admission to our hosptial ]
wound complications; pulmonary infection; incisional hernia, and bleeding.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Prospective Study of The Complement Depletion in Patients With Severe Abdominal Sepsis
Official Title  ICMJE The Complement C3 Depletion in Patients With Severe Abdominal Sepsis: Risk Prediction and the Association With Down-regulated Adaptive Immunity
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Condition  ICMJE
  • Severe Sepsis
  • Pancreatitis
  • Abdominal Abscess
  • Appendicitis
  • Digestive System Fistula
Intervention  ICMJE
  • 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.
Study Arms  ICMJE Not Provided
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 5, 2012)
75
Original Actual Enrollment  ICMJE
 (submitted: March 30, 2012)
70
Actual Study Completion Date  ICMJE March 2012
Actual Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01568853
Other Study ID Numbers  ICMJE BK2010-017-1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jianan Ren, Jinling Hospital, China
Study Sponsor  ICMJE Jinling Hospital, China
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jianan Ren, M.D. Department of Surgery, Jinling Hospital, China
PRS Account Jinling Hospital, China
Verification Date April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP