SepsisNCT02285257
Epidemiology of Sepsis at Yuetan Subdistrict in Beijing
An observational study of Sepsis, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
The purpose of this study is to determine the epidemiology and outcome of sepsis at Yuetan subdistrict in Beijing in mainland China). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- Jul 2013to Jun 2016
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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".
Who may be able to join
- 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"
Who cannot join
- Age<18 years
- Lived in Yuetan Subdistrict less than 1 year
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
MICU of Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Bin Du, professor, 8613601366216, dubin98@gmail.com
Bin Du, Doctor
About this study
The purpose of this study is to determine the epidemiology and outcome of sepsis at Yuetan subdistrict in Beijing in mainland China).
Read the detailed description
- 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.
- 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.
- 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".
- Conditions
- Sepsis
- Keywords
- Sepsis, Severe sepsis, septic shock, epidemiology, outcome
- Medical subject headings
- Sepsis, Shock, Septic
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of sepsis of people living in Yuetan subdistrict in Beijing
Measured: 2012-7-1~2014-6-30, up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2014 (estimated)
- Study startJul 2013
- Primary completionJun 2016 (estimated)
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bin Du, professor, Study director, Medical ICU, Peking Union Medical College Hospital, Peking Union Medical College & Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02285257
- Sponsor's protocol ID
- MICU2014-1
- Other IDs
- Z131107002213112
- Status last verified
- Oct 2014
- First submitted
- 4 Nov 2014
- Last updated
- 6 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 31425273
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology of Sepsis at Yuetan Subdistrict in Beijing
- ClinicalTrials.gov ID
- NCT02285257
- Acronym / sponsor ID
- MICU2014-1
- Conditions
- Sepsis
- Keywords
- Sepsis, Severe sepsis, septic shock, epidemiology, outcome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 6 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the epidemiology and outcome of sepsis at Yuetan subdistrict in Beijing in mainland China).
Detailed description
- 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.
- 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.
- 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 design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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".
Key inclusion criteria (3 listed)
- 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"
Key exclusion criteria (2 listed)
- Age<18 years
- Lived in Yuetan Subdistrict less than 1 year
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
incidence of sepsis of people living in Yuetan subdistrict in Beijing
Time frame: 2012-7-1~2014-6-30, up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2014.
- Derived from this study: PubMed 31425273Tian 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bin Du, professor study director
Medical ICU, Peking Union Medical College Hospital, Peking Union Medical College & Chinese Academy of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bin Du, professor (8613601366216, dubin98@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of sepsis of people living in Yuetan subdistrict in Beijing (time frame: 2012-7-1~2014-6-30, up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02285257, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2014.