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Epidemiology of Sepsis in China

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ClinicalTrials.gov Identifier: NCT02448472
Recruitment Status : Completed
First Posted : May 19, 2015
Last Update Posted : February 17, 2016
Sponsor:
Information provided by (Responsible Party):
Jianfeng Xie, Southeast University, China

Brief Summary:
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 or disease Intervention/treatment
Sepsis Other: Observational study, none intervention

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 : Observational
Estimated Enrollment : 2000 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Chinese Epidemiological Study of Severe Sepsis.(CHESS Study)
Study Start Date : November 2015
Primary Completion Date : December 2015
Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis
U.S. FDA Resources




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

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


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


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

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 Posted: May 19, 2015    Key Record Dates
Last Update Posted: February 17, 2016
Last Verified: October 2015

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