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Epidemiology of Sepsis in China

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02448472
First Posted: May 19, 2015
Last Update Posted: February 17, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Jianfeng Xie, Southeast University, China
  Purpose
Sepsis is a common cause for morbidity and mortality in critically ill patients. In USA, the incidence of sepsis is about 3/1000 population. However, the incidence of sepsis varies among different clinic trails. In addition, clinician empirical select antibiotic according to the epidemiology of sepsis, however, the etiology of sepsis is various in different studies. In China, the MDRO is much higher than western country. There is no study about the epidemiology of sepsis in China. Therefore, it is necessary to conduct a study about it in China.

Condition Intervention
Sepsis Other: Observational study, none intervention

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Chinese Epidemiological Study of Severe Sepsis.(CHESS Study)

Resource links provided by NLM:


Further study details as provided by Jianfeng Xie, Southeast University, China:

Primary Outcome Measures:
  • Incidence [ Time Frame: Patients will be assessed up to 90 days ]
  • Mortality [ Time Frame: Sepsis and severe sepsis patients will be assessed up to 90 days ]

Secondary Outcome Measures:
  • etiology [ Time Frame: The pathogen of sepsis will be assessed up to 90 days ]

Estimated Enrollment: 2000
Study Start Date: November 2015
Study Completion Date: January 2016
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Sepsis patient who admitted into ICU
Criteria

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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02448472


Locations
China, Jiangsu
Zhongda hospital, Southeast University
Nanjing, Jiangsu, China, 210009
Sponsors and Collaborators
Jianfeng Xie
Investigators
Study Director: Yang Yi, Ph.D. Zhongda hospital, Southeast University
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jianfeng Xie, Attending, Southeast University, China
ClinicalTrials.gov Identifier: NCT02448472     History of Changes
Other Study ID Numbers: 20150315
First Submitted: April 11, 2015
First Posted: May 19, 2015
Last Update Posted: February 17, 2016
Last Verified: October 2015

Additional relevant MeSH terms:
Sepsis
Toxemia
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes