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
1 other identifier
interventional
75
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2011
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedFirst Submitted
Initial submission to the registry
March 29, 2012
CompletedFirst Posted
Study publicly available on registry
April 2, 2012
CompletedApril 6, 2012
April 1, 2012
4 months
March 29, 2012
April 5, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Postoperative complications
within the first 28 days after admission to our hosptial
Interventions
Intravenously, 10 ug/min, 24 hours
IAH \>=20 mmHg, and ACS emerged, such as low urine and decreased FiO2 quickly.
500-1500 kcal/day; Nasogastric tube feeding;
3000 mL parenteral nutrition fluid, intravenously.
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of severe abdominal sepsis
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Surgery, Jinling Hospital
Nanjing, Jiangsu, 210002, China
Related Publications (1)
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.
PMID: 23091606DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jianan Ren, M.D.
Department of Surgery, Jinling Hospital, China
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical professor, Principal investigator
Study Record Dates
First Submitted
March 29, 2012
First Posted
April 2, 2012
Study Start
November 1, 2011
Primary Completion
March 1, 2012
Study Completion
March 1, 2012
Last Updated
April 6, 2012
Record last verified: 2012-04