SepsisNCT05602584
Effect of Immunophenotype on Prognosis of Sepsis
An observational study of Sepsis and Septic Shock, run by Southeast University, China at 1 site in China.
Trial summary
The popuse of this study is to assess the inflammatory immunophenotypes of sepsis patients are significantly correlated with prognosis, which may provide theoretical basis for precise immune regulation of sepsis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Septic Shock, Sepsis Syndrome
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2021to 1 Dec 2023
- How long will I take part?
- 3 Months
- 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: We investigate the patients with sepsis 3 diagnostic criteria were admitted to ICU; Aged 18 or above; Within 24 hours of diagnosis.
Inclusion Criteria:Patients with sepsis 3 diagnostic criteria were admitted to ICU; Aged 18 or above; Within 24 hours of diagnosis.
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Exclusion Criteria:Malignant tumor; Autoimmune diseases; Diseases of the blood system; HIV infection; History of high-dose glucocorticoid use (hydrocortisone 200mg/d or other hormone with equivalent titer, more than one week); pregnancy
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Trial locations and contacts
1 site in 1 country.
China1 site
Department of Critical Care , Zhong-da Hospital
Nanjing, Jiangsu, 210009
About this study
Official title: The Effect of Immunophenotype on Prognosis of Sepsis
The popuse of this study is to assess the inflammatory immunophenotypes of sepsis patients are significantly correlated with prognosis, which may provide theoretical basis for precise immune regulation of sepsis.
Read the detailed description
The clinical characteristics and inflammatory/immune markers of sepsis patients were analyzed dynamically and followed up to one year after diagnosis. Through latent category analysis, cluster analysis and other inflammatory immunophenotypes, the clinical characteristics of different inflammatory immunophenotypes and their relationship with the long-term prognosis of sepsis were clarified.
- Conditions
- Sepsis, Septic Shock, Sepsis Syndrome
- Keywords
- Immunophenotype
- Medical subject headings
- Sepsis, Shock, Septic, Systemic Inflammatory Response Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
survival or death in 28 days
observe wether the patients is survival or death in 28 days
Measured: From date of randomization until the date of out of ICU or date of death from any cause, whichever came first, assessed up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2022
- Study start1 Oct 2021
- Primary completion1 Oct 2023 (estimated)
- Study completion1 Dec 2023 (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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Southeast University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianfeng Xie, Southeast University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05602584
- Sponsor's protocol ID
- EOIPOPOS
- Status last verified
- Oct 2022
- First submitted
- 2 Jul 2022
- Last updated
- 2 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Immunophenotype on Prognosis of Sepsis
- ClinicalTrials.gov ID
- NCT05602584
- Acronym / sponsor ID
- EOIPOPOS
- Conditions
- Sepsis, Septic Shock, Sepsis Syndrome
- Keywords
- Immunophenotype
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Southeast University, ChinaUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 2 Nov 2022 (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 popuse of this study is to assess the inflammatory immunophenotypes of sepsis patients are significantly correlated with prognosis, which may provide theoretical basis for precise immune regulation of sepsis.
Detailed description
The clinical characteristics and inflammatory/immune markers of sepsis patients were analyzed dynamically and followed up to one year after diagnosis. Through latent category analysis, cluster analysis and other inflammatory immunophenotypes, the clinical characteristics of different inflammatory immunophenotypes and their relationship with the long-term prognosis of sepsis were clarified.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We investigate the patients with sepsis 3 diagnostic criteria were admitted to ICU; Aged 18 or above; Within 24 hours of diagnosis.
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
survival or death in 28 days
Time frame: From date of randomization until the date of out of ICU or date of death from any cause, whichever came first, assessed up to 28 days
observe wether the patients is survival or death in 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2022.
- Individual participant dataSharing planned: No
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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.
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 Septic Shock, 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?
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 2 Nov 2022. 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?
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?
survival or death in 28 days (time frame: From date of randomization until the date of out of ICU or date of death from any cause, whichever came first, assessed up to 28 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 2 Nov 2022.