- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02448472
Epidemiology of Sepsis in China
Chinese Epidemiological Study of Severe Sepsis.(CHESS Study)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Sepsis,especially severe sepsis is a major cause of admission to the intensive care unit (ICU) and death. In USA, the incidence of sepsis is about 3/1000 population. However, the incidence of sepsis varies among different clinic trails. Between 6 and 54% of patients admitted to ICUs have severe sepsis and the mortality rate for these patients varies from 20 to 60%. There is no exactly results of incidence of sepsis in China.
In addition, clinician empirical select antibiotic according to the epidemiology of sepsis, however, the etiology of sepsis is various in different studies. In EPIC II study, the organisms of sepsis include Gram-positive microorganisms (69.8%),Gram-negative microorganisms(62.2%) and fungi (17%). In China, the MDRO is much higher than western country. In contrast to EPIC II study, one study in China showed that the organisms of sepsis include Gram-positive microorganisms (14.5%),Gram-negative microorganisms(62.5%) and fungi (2.2%). Therefore, it is necessary to conduct a study about epidemiology of sepsis in China.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Jiangsu
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Nanjing, Jiangsu, China, 210009
- Zhongda Hospital, Southeast University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
sepsis patients who admitted into ICU during research period (include patients with sepsis at ICU admission and patients who has new sepsis during ICU period)
Exclusion Criteria:
The patients with second sepsis in ICU
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Incidence
Time Frame: Patients will be assessed up to 90 days
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Patients will be assessed up to 90 days
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Mortality
Time Frame: Sepsis and severe sepsis patients will be assessed up to 90 days
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Sepsis and severe sepsis patients will be assessed up to 90 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
etiology
Time Frame: The pathogen of sepsis will be assessed up to 90 days
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The pathogen of sepsis will be assessed up to 90 days
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Yang Yi, Ph.D., Zhongda Hospital
Publications and helpful links
General Publications
- Xie J, Wang H, Kang Y, Zhou L, Liu Z, Qin B, Ma X, Cao X, Chen D, Lu W, Yao C, Yu K, Yao X, Shang H, Qiu H, Yang Y; CHinese Epidemiological Study of Sepsis (CHESS) Study Investigators. The Epidemiology of Sepsis in Chinese ICUs: A National Cross-Sectional Survey. Crit Care Med. 2020 Mar;48(3):e209-e218. doi: 10.1097/CCM.0000000000004155.
- Yang Y, Xie JF, Yu KJ, Yao C, Li JG, Guan XD, Yan J, Ma XC, Kang Y, Yang CS, Yao XQ, Shang HC, Qiu HB; for CHESS Study Investigators. Epidemiological Study of Sepsis in China: Protocol of a Cross-sectional Survey. Chin Med J (Engl). 2016 Dec 20;129(24):2967-2973. doi: 10.4103/0366-6999.195474.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20150315
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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