SepsisCHINA-SEPNCT07066553
Outcomes of Sepsis Patients in China (CHINA-SEP)
An observational study of Sepsis, run by Southeast University, China at 1 site in China.
Trial summary
Sepsis poses a significant public health challenge in China. However, longitudinal real-world evidence on guideline adherence and patient outcomes remains scarce. This registry aims to address these gaps by systematically capturing guideline-concordant treatment patterns and associated outcomes in ICU patients… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis
- How many people
- 5,775 participants
- Where
- 1 siteChina
- Study dates
- 18 Jul 2025to Aug 2027
- How long will I take part?
- 28 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Patients diagnosed with sepsis (Sepsis-3 criteria) upon ICU admission
Who may be able to join
- Hospitalized patients aged ≥18 years
- Sepsis diagnosis meeting Sepsis-3 criteria
- Informed consent signed by patient or legally authorized representative
Who cannot join
- Patients with a prior history of sepsis
- Sepsis diagnosis >48 hours prior to enrollment
- Current participation in clinical trial
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Outcomes of Sepsis Patients in China: A Registry
Sepsis poses a significant public health challenge in China. However, longitudinal real-world evidence on guideline adherence and patient outcomes remains scarce. This registry aims to address these gaps by systematically capturing guideline-concordant treatment patterns and associated outcomes in ICU patients diagnosed according to Sepsis-3.0 criteria across diverse settings, thereby generating actionable evidence to improve the quality of sepsis care nationwide.
Read the detailed description
Sepsis is a major public health challenge in China and remains one of the leading causes of intensive care unit (ICU) admissions, accounting for approximately 20.6% of all ICU cases. However, longitudinal real-world data on adherence to clinical guidelines and associated patient outcomes remain limited. This multicenter observational registry is designed to systematically capture real-world management data from adult ICU patients diagnosed with sepsis according to Sepsis-3.0 criteria. The study will assess current treatment practices and document infection types, anatomical sites, pathogen profiles, and key clinical outcomes. By examining the relationship between treatment patterns and outcomes, this study aims to generate actionable evidence to improve the quality of sepsis care in China. The findings will help identify practice variability, support updates to national guidelines, and promote standardized, evidence-based management across the country.
- Conditions
- Sepsis
- Keywords
- China, Sepsis, Intensive Care Unit, Outcomes
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Sepsis Group | The sepsis group comprised patients diagnosed with sepsis (Sepsis-3 criteria). |
What is being measured
The primary outcome is the main question the study is designed to answer.
28-day all-cause mortality
Measured: 28 days after enrollment.
Secondary outcomes (3)
Rate of compliance with sepsis bundle elements
This outcome quantifies the compliance rate, defined as the proportion of patients who completed all required sepsis bundle elements within the assigned 1-, 3-, or 6-hour window from time zero (time of sepsis recognition). Compliance rate is calculated as the number of patients who completed all clinically indicated bundle elements within the assigned time frame divided by the total number of eligible patients. The bundle elements include serum lactate measurement, blood culture collection prior to antibiotic administration, initiation of intravenous antibiotics, and administration of intravenous crystalloids for patients with hypotension or lactate levels greater than 4 mmol/L.
Measured: Patient compliance with sepsis bundles will be assessed within 24 hours after ICU admission.
ICU mortality
Measured: From ICU admission to ICU discharge or death, up to 28 days
Ventilator-free days
Measured: 28 days after enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2025
- Study start18 Jul 2025 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- 5,775 participants (estimated)
- Target duration
- 28 Days
Sponsor and investigators
- Lead sponsor
- Southeast University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Songqiao Liu, Southeast University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07066553
- Sponsor's protocol ID
- 2025ZDSYLL251-P01
- Acronym
- CHINA-SEP
- Status last verified
- Jul 2025
- First submitted
- 30 Jun 2025
- Last updated
- 15 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 31804299Rudd KE, Johnson SC, Agesa KM, Shackelford KA, Tsoi D, Kievlan DR, Colombara DV, Ikuta KS, Kissoon N, Finfer S, Fleischmann-Struzek C, Machado FR, Reinhart KK, Rowan K, Seymour CW, Watson RS, West TE, Marinho F, Hay SI, Lozano R, Lopez AD, Angus DC, Murray CJL, Naghavi M. Global, regional, and national sepsis incidence and mortality, 1990-2017: analysis for the Global Burden of Disease Study. Lancet. 2020 Jan 18;395(10219):200-211. doi: 10.1016/S0140-6736(19)32989-7.
PubMed 31954465Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287.
PubMed 26903338
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Sepsis Patients in China: A Registry
- ClinicalTrials.gov ID
- NCT07066553
- Acronym / sponsor ID
- CHINA-SEP / 2025ZDSYLL251-P01
- Conditions
- Sepsis
- Keywords
- China, Sepsis, Intensive Care Unit, Outcomes
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 5,775 participants (estimated)
- Lead sponsor
- Southeast University, ChinaUniversity, hospital or other
- Study start
- 18 Jul 2025 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 15 Jul 2025 (actual)
- 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 poses a significant public health challenge in China. However, longitudinal real-world evidence on guideline adherence and patient outcomes remains scarce. This registry aims to address these gaps by systematically capturing guideline-concordant treatment patterns and associated outcomes in ICU patients diagnosed according to Sepsis-3.0 criteria across diverse settings, thereby generating actionable evidence to improve the quality of sepsis care nationwide.
Detailed description
Sepsis is a major public health challenge in China and remains one of the leading causes of intensive care unit (ICU) admissions, accounting for approximately 20.6% of all ICU cases. However, longitudinal real-world data on adherence to clinical guidelines and associated patient outcomes remain limited. This multicenter observational registry is designed to systematically capture real-world management data from adult ICU patients diagnosed with sepsis according to Sepsis-3.0 criteria. The study will assess current treatment practices and document infection types, anatomical sites, pathogen profiles, and key clinical outcomes. By examining the relationship between treatment patterns and outcomes, this study aims to generate actionable evidence to improve the quality of sepsis care in China. The findings will help identify practice variability, support updates to national guidelines, and promote standardized, evidence-based management across the country.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 28 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sepsis Group | – | –The sepsis group comprised patients diagnosed with sepsis (Sepsis-3 criteria). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with sepsis (Sepsis-3 criteria) upon ICU admission
Key inclusion criteria (3 listed)
- Hospitalized patients aged ≥18 years
- Sepsis diagnosis meeting Sepsis-3 criteria
- Informed consent signed by patient or legally authorized representative
Key exclusion criteria (3 listed)
- Patients with a prior history of sepsis
- Sepsis diagnosis >48 hours prior to enrollment
- Current participation in clinical trial
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
28-day all-cause mortality
Time frame: 28 days after enrollment.
3 secondary outcomes
Rate of compliance with sepsis bundle elements
Time frame: Patient compliance with sepsis bundles will be assessed within 24 hours after ICU admission.
ICU mortality
Time frame: From ICU admission to ICU discharge or death, up to 28 days
Ventilator-free days
Time frame: 28 days after enrollment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2025.
- Background: 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.
- Background: PubMed 31954465Rudd KE, Johnson SC, Agesa KM, Shackelford KA, Tsoi D, Kievlan DR, Colombara DV, Ikuta KS, Kissoon N, Finfer S, Fleischmann-Struzek C, Machado FR, Reinhart KK, Rowan K, Seymour CW, Watson RS, West TE, Marinho F, Hay SI, Lozano R, Lopez AD, Angus DC, Murray CJL, Naghavi M. Global, regional, and national sepsis incidence and mortality, 1990-2017: analysis for the Global Burden of Disease Study. Lancet. 2020 Jan 18;395(10219):200-211. doi: 10.1016/S0140-6736(19)32989-7.
- Background: PubMed 26903338Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287.
- Individual participant dataSharing planned: Undecided
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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.
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 Southeast University, China 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 3 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: opening soon, as of the sponsor's last update on 15 Jul 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Professor Liu Songqiao (+86 25 83262553, liusongqiao@ymail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
28-day all-cause mortality (time frame: 28 days after enrollment.). 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 NCT07066553, which also lists 3 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 15 Jul 2025.