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Epidemiology of Sepsis at Yuetan Subdistrict in Beijing

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ClinicalTrials.gov Identifier: NCT02285257
Recruitment Status : Unknown
Verified October 2014 by Peking Union Medical College Hospital.
Recruitment status was:  Recruiting
First Posted : November 6, 2014
Last Update Posted : November 6, 2014
Sponsor:
Information provided by (Responsible Party):
Peking Union Medical College Hospital

Tracking Information
First Submitted Date November 4, 2014
First Posted Date November 6, 2014
Last Update Posted Date November 6, 2014
Study Start Date July 2013
Estimated Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 5, 2014)
incidence of sepsis of people living in Yuetan subdistrict in Beijing [ Time Frame: 2012-7-1~2014-6-30, up to 2 years ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Epidemiology of Sepsis at Yuetan Subdistrict in Beijing
Official Title Epidemiology of Sepsis at Yuetan Subdistrict in Beijing
Brief Summary The purpose of this study is to determine the epidemiology and outcome of sepsis at Yuetan subdistrict in Beijing in mainland China).
Detailed Description
  1. Questionnaires were used to collect the characteristic information of people living in Yuetan subdistrict in Beijing and select people who had been hospitalized because of any reasons between July 2012 and June 2014.
  2. Data were collected on all patients admitted into different hospitals during the study period. The following information was recorded:demographic characteristics and admission category (whether medical, scheduled surgery, nonoperative trauma, or unscheduled surgery), presence of preexisting organ insufficiency,using definitions included in the Acute Physiology and Chronic Health Evaluation (APACHE) II score11; co- morbidities and the estimated prognosis of any preexisting underlying disease, following the classification of McCabe and Jackson.
  3. Patients were included in the study cohort when having, in association with a documented or strongly suspected infection and fullfil the diagnostic criteria of sepsis according to the "Surviving Sepsis Campaign: International guidelines for management of severe sepsis and septic shock:2012".
Study Type Observational [Patient Registry]
Study Design Observational Model: Ecologic or Community
Time Perspective: Prospective
Target Follow-Up Duration 1 Year
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Questionnaires were used to collect the characteristic information of people living in Yuetan subdistrict in Beijing for more than 1 years people who had been hospitalized because of any reasons between July 2012 and June 2014 were selected.Patients were included in the study cohort when having, in association with a documented or strongly suspected infection and fullfil the diagnostic criteria of sepsis according to the "Surviving Sepsis Campaign:International guidelines for management of severe sepsis and septic shock:2012".
Condition Sepsis
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Tian HC, Zhou JF, Weng L, Hu XY, Peng JM, Wang CY, Jiang W, Du XP, Xi XM, An YZ, Duan ML, Du B; for China Critical Care Clinical Trials Group (CCCCTG). Epidemiology of Sepsis-3 in a sub-district of Beijing: secondary analysis of a population-based database. Chin Med J (Engl). 2019 Sep 5;132(17):2039-2045. doi: 10.1097/CM9.0000000000000392.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: November 5, 2014)
1000
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 2016
Estimated Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Age≥18 years;
  • Having lived in Yuetan Subdistirct for at least 1 year
  • Having, in association with a documented or strongly suspected infection and fullfil the diagnostic criteria of sepsis according to the "Surviving Sepsis Campaign:International guidelines for management of severe sepsis and septic shock:2012"

Exclusion Criteria:

  • Age<18 years
  • Lived in Yuetan Subdistrict less than 1 year
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT02285257
Other Study ID Numbers MICU2014-1
Z131107002213112 ( Other Grant/Funding Number: Beijing Municipal Science and Technology Commission )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Peking Union Medical College Hospital
Study Sponsor Peking Union Medical College Hospital
Collaborators Not Provided
Investigators
Study Director: Bin Du, professor Medical ICU, Peking Union Medical College Hospital, Peking Union Medical College & Chinese Academy of Medical Sciences
PRS Account Peking Union Medical College Hospital
Verification Date October 2014