SepsisNCT06523075
Host Dysregulation-Driven Sepsis Prediction Model
An observational study of Sepsis, run by Second Affiliated Hospital of Wenzhou Medical University at 2 sites in China.
Trial summary
The aim of this study is to identify risk factors associated with sepsis and to construct a predictive model for sepsis. This will provide an objective theoretical and empirical foundation for the diagnosis, assessment, and management of sepsis in our country.The primary questions addressed are: What are the risk… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis
- What is being tested?
- Tumor Necrosis Factor, Interleukin-1β and Interleukin-12
- How many people
- 1,000 participants
- Where
- 2 sitesChina
- Study dates
- 1 Sep 2024to 17 Oct 2024
- 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
- Adult, Older adult
Study population: Patients with Infection or Suspected Infection
Who may be able to join
- Patients with Infection or Suspected Infection
Who cannot join
- Patients with Autoimmune Diseases
- Pregnant Women
- Patients with Advanced-Stage Cancer and Systemic Metastasis
Trial locations and contacts
2 sites in 1 country.
China2 sites
Xiue Ye
Wenzhou, Zhejiang, 325000
The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University,
Wenzhou, Zhejiang, 325027
About this study
Official title: Construction and Validation of a Sepsis Prediction Model Based on Dysregulation of Host Response
The aim of this study is to identify risk factors associated with sepsis and to construct a predictive model for sepsis. This will provide an objective theoretical and empirical foundation for the diagnosis, assessment, and management of sepsis in our country.The primary questions addressed are:
What are the risk factors for the development of sepsis? How do we improve the prognosis of sepsis?
- Conditions
- Sepsis
- Being tested
- Tumor Necrosis Factor, Interleukin-1β, Interleukin-12, Interleukin-18, Complement C3
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tumor Necrosis FactorOther
This study is a retrospective observational study, with Tumor Necrosis Factor being one of the exposure factors under investigation.
Interleukin-1βOther
This study is a retrospective observational study, with Interleukin-1β being one of the exposure factors under investigation.
Interleukin-12Other
This study is a retrospective observational study, with Interleukin-12 being one of the exposure factors under investigation.
Interleukin-18Other
This study is a retrospective observational study, with Interleukin-18 being one of the exposure factors under investigation.
Complement C3Other
This study is a retrospective observational study, with Complement C3 being one of the exposure factors under investigation.
Complement C5Other
This study is a retrospective observational study, with Complement C5 being one of the exposure factors under investigation.
| Study group | Role | What they receive |
|---|---|---|
| Sepsis Group | Not described Receives: Other: Tumor Necrosis Factor; Other: Interleukin-1β; Other: Interleukin-12; Other: Interleukin-18; Other: Complement C3; Other: Complement C5 | |
| Non-Sepsis Group | Not described Receives: Other: Tumor Necrosis Factor; Other: Interleukin-1β; Other: Interleukin-12; Other: Interleukin-18; Other: Complement C3; Other: Complement C5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sepsis
A rapid increase of 2 or more points points in the Sequential Organ Failure Assessment (SOFA) score after patient infection.SOFA score, which ranges from a minimum of 2 to a maximum of 15, indicates a worse outcome with higher scores.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2024
- Study start1 Sep 2024
- Primary completion13 Oct 2024
- Study completion17 Oct 2024
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.
- More trials run by Second Affiliated Hospital of Wenzhou Medical UniversityThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06523075
- Sponsor's protocol ID
- SAHoWMU-CR2024-16-214
- Status last verified
- Oct 2024
- First submitted
- 14 Jul 2024
- Last updated
- 31 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Construction and Validation of a Sepsis Prediction Model Based on Dysregulation of Host Response
- ClinicalTrials.gov ID
- NCT06523075
- Acronym / sponsor ID
- SAHoWMU-CR2024-16-214
- Conditions
- Sepsis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Second Affiliated Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 13 Oct 2024 (actual)
- Study completion
- 17 Oct 2024 (actual)
- First posted
- 26 Jul 2024 (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 aim of this study is to identify risk factors associated with sepsis and to construct a predictive model for sepsis. This will provide an objective theoretical and empirical foundation for the diagnosis, assessment, and management of sepsis in our country.The primary questions addressed are:
What are the risk factors for the development of sepsis? How do we improve the prognosis of sepsis?
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sepsis Group | – | Other: Tumor Necrosis Factor, Other: Interleukin-1β, Other: Interleukin-12, Other: Interleukin-18, Other: Complement C3, Other: Complement C5 |
| Non-Sepsis Group | – | Other: Tumor Necrosis Factor, Other: Interleukin-1β, Other: Interleukin-12, Other: Interleukin-18, Other: Complement C3, Other: Complement C5 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with Infection or Suspected Infection
Key inclusion criteria (1 listed)
- Patients with Infection or Suspected Infection
Key exclusion criteria (3 listed)
- Patients with Autoimmune Diseases
- Pregnant Women
- Patients with Advanced-Stage Cancer and Systemic Metastasis
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 |
|---|---|---|
| Tumor Necrosis FactorThis study is a retrospective observational study, with Tumor Necrosis Factor being one of the exposure factors under investigation. | Other | Non-Sepsis Group, Sepsis Group |
| Interleukin-1βThis study is a retrospective observational study, with Interleukin-1β being one of the exposure factors under investigation. | Other | Non-Sepsis Group, Sepsis Group |
| Interleukin-12This study is a retrospective observational study, with Interleukin-12 being one of the exposure factors under investigation. | Other | Non-Sepsis Group, Sepsis Group |
| Interleukin-18This study is a retrospective observational study, with Interleukin-18 being one of the exposure factors under investigation. | Other | Non-Sepsis Group, Sepsis Group |
| Complement C3This study is a retrospective observational study, with Complement C3 being one of the exposure factors under investigation. | Other | Non-Sepsis Group, Sepsis Group |
| Complement C5This study is a retrospective observational study, with Complement C5 being one of the exposure factors under investigation. | Other | Non-Sepsis Group, Sepsis Group |
Primary outcome
Sepsis
Time frame: 3 months
A rapid increase of 2 or more points points in the Sequential Organ Failure Assessment (SOFA) score after patient infection.SOFA score, which ranges from a minimum of 2 to a maximum of 15, indicates a worse outcome with higher scores.
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 31 Oct 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites 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 Second Affiliated Hospital of Wenzhou Medical University at 2 sites 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 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: finished, as of the sponsor's last update on 31 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Sepsis (time frame: 3 months). 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 31 Oct 2024.