Sepsissepsis modelNCT06904001
Study on the Construction and Application of Early Warning Model of Sepsis in Critically Ill Patients
An observational study of Sepsis and Sepsis and Septic Shock, run by Second Affiliated Hospital of Wenzhou Medical University at 1 site in China.
Trial summary
The condition of sepsis patients changes rapidly, whom are often accompanied by impaired respiratory, circulatory, renal, and coagulation functions. So far, the prognosis of sepsis at home and abroad is not ideal. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Sepsis, Sepsis and Septic Shock, Infection
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 30 Dec 2025
- How long will I take part?
- 2 Months
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to the ICU with sepsis, aged over 18 years.
Who may be able to join
- Temperature > 38°C or < 36°C;
- Heart rate > 90 beats/min;
- Respiratory rate > 20 breaths/min or PaCO₂ < 32 mmHg;
- White blood cell count > 12.0 × 10⁹/L or < 4.0 × 10⁹/L, or > 10% immature neutrophils;
- Initial septic shock diagnosis;
- Organ dysfunction (cardiovascular, respiratory, or ≥ 2 other organs);
- Complete clinical data.
Who cannot join
- Cancer history;
- Chemotherapy;
- Radiotherapy;
- Incomplete data.
- Controls were free of infectious or inflammatory diseases and glucocorticoid use.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000
About this study
The condition of sepsis patients changes rapidly, whom are often accompanied by impaired respiratory, circulatory, renal, and coagulation functions. So far, the prognosis of sepsis at home and abroad is not ideal. Participants was randomly included in this research project on the pathogenesis and prevention of sepsis due to typical sepsis symptoms. the investigators will collect appropriate clinical specimens for analysis of immune cell functions and pathogenic microorganisms combined with individual patient research. This study will enable sepsis patients to be identified early and receive earlier anti-sepsis treatment, which is expected to improve the prognosis of sepsis, shorten hospitalization time, and reduce treatment costs.
The above-mentioned tests and analyses do not increase the economic burden on the participants, and the required expenses are all paid from the project funds; they do not affect the prognosis and rehabilitation process of participants, and do not have adverse effects on the health of participants.
- Conditions
- Sepsis, Sepsis and Septic Shock, Infection
- Keywords
- sepsis, septic shock, biomarker, warning model
- Medical subject headings
- Sepsis, Shock, Septic, Infections
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 and control | The presence of sepsis at the time of admission to the ICU is called sepsis, and the absence of sepsis is called control. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death
Whether death occurred during hospitalization
Measured: From the date of first ICU admission to the date of ICU discharge (whether due to death or clinical improvement), 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 posted1 Apr 2025
- Study start1 Jan 2019
- Primary completion30 Dec 2022
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 2 Months
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital of Wenzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06904001
- Sponsor's protocol ID
- SAHOWMU-CR2018-11-129
- Acronym
- sepsis model
- Status last verified
- Mar 2025
- First submitted
- 11 Mar 2025
- Last updated
- 1 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Protecting patient privacy
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Construction and Application of Early Warning Model of Sepsis in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT06904001
- Acronym / sponsor ID
- sepsis model / SAHOWMU-CR2018-11-129
- Conditions
- Sepsis, Sepsis and Septic Shock, Infection
- Keywords
- sepsis, septic shock, biomarker, warning model
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 1 Apr 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.
The condition of sepsis patients changes rapidly, whom are often accompanied by impaired respiratory, circulatory, renal, and coagulation functions. So far, the prognosis of sepsis at home and abroad is not ideal. Participants was randomly included in this research project on the pathogenesis and prevention of sepsis due to typical sepsis symptoms. the investigators will collect appropriate clinical specimens for analysis of immune cell functions and pathogenic microorganisms combined with individual patient research. This study will enable sepsis patients to be identified early and receive earlier anti-sepsis treatment, which is expected to improve the prognosis of sepsis, shorten hospitalization time, and reduce treatment costs.
The above-mentioned tests and analyses do not increase the economic burden on the participants, and the required expenses are all paid from the project funds; they do not affect the prognosis and rehabilitation process of participants, and do not have adverse effects on the health of participants.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 2 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| sepsis and control | – | –The presence of sepsis at the time of admission to the ICU is called sepsis, and the absence of sepsis is called control. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to the ICU with sepsis, aged over 18 years.
Key inclusion criteria (7 listed)
- Temperature > 38°C or < 36°C;
- Heart rate > 90 beats/min;
- Respiratory rate > 20 breaths/min or PaCO₂ < 32 mmHg;
- White blood cell count > 12.0 × 10⁹/L or < 4.0 × 10⁹/L, or > 10% immature neutrophils;
- Initial septic shock diagnosis;
Key exclusion criteria (5 listed)
- Cancer history;
- Chemotherapy;
- Radiotherapy;
- Incomplete data.
- Controls were free of infectious or inflammatory diseases and glucocorticoid use.
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
Death
Time frame: From the date of first ICU admission to the date of ICU discharge (whether due to death or clinical improvement), assessed up to 90 days.
Whether death occurred during hospitalization
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 1 Apr 2025.
- Individual participant dataSharing planned: No. Protecting patient privacy
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Sepsis and Septic Shock, run by Second Affiliated Hospital of Wenzhou Medical University 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 7 inclusion and 5 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: enrolling by invitation, as of the sponsor's last update on 1 Apr 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?
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?
Death (time frame: From the date of first ICU admission to the date of ICU discharge (whether due to death or clinical improvement), assessed up to 90 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Apr 2025.