SepsisNCT02448472
Epidemiology of Sepsis in China
An observational study of Sepsis, run by Jianfeng Xie at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Sepsis
- What is being tested?
- Observational study, none intervention
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- Nov 2015to Jan 2016
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Sepsis patient who admitted into ICU
Who may be able to join
- 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)
Who cannot join
- The patients with second sepsis in ICU
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Chinese Epidemiological Study of Severe Sepsis.(CHESS Study)
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.
Read the 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.
- Conditions
- Sepsis
- Being tested
- Observational study, none intervention
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational study, none interventionOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence
Measured: Patients will be assessed up to 90 days
Mortality
Measured: Sepsis and severe sepsis patients will be assessed up to 90 days
Secondary outcomes (1)
etiology
Measured: The pathogen of sepsis will be assessed up to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2015 (estimated)
- Study startNov 2015
- Primary completionDec 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jianfeng Xie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jianfeng Xie, Southeast University, China
- Investigators
- Yang Yi, Ph.D., Study director, Zhongda Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02448472
- Sponsor's protocol ID
- 20150315
- Status last verified
- Oct 2015
- First submitted
- 11 Apr 2015
- Last updated
- 17 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 31804299Yang 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.
PubMed 27958229
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chinese Epidemiological Study of Severe Sepsis.(CHESS Study)
- ClinicalTrials.gov ID
- NCT02448472
- Acronym / sponsor ID
- 20150315
- Conditions
- Sepsis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Jianfeng XieUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 19 May 2015 (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.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Sepsis patient who admitted into ICU
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (1 listed)
- The patients with second sepsis in ICU
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational study, none intervention | Other | – |
Primary outcome
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
1 secondary outcome
etiology
Time frame: The pathogen of sepsis will be assessed up to 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2016.
- Derived from this study: PubMed 31804299Xie 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.
- Derived from this study: PubMed 27958229Yang 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.
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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.
Yang Yi, Ph.D. study director
Zhongda Hospital
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 Jianfeng Xie 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 17 Feb 2016. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence (time frame: Patients will be assessed up to 90 days). The study lists 2 primary outcomes in all. 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 NCT02448472, which also lists 2 linked publications.
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 17 Feb 2016.