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Status unknownNCT05602584Updated Nov 2, 2022

Effect of Immunophenotype on Prognosis of Sepsis

An observational study in Sepsis, Septic Shock and Sepsis Syndrome, sponsored by Southeast University, China. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-11-02.

Sponsored by Southeast University, China · Observational

The sponsor has not verified this record recently (last verified Oct 2022), so the status shown — last known as Enrolling by invitation — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
18 Years and older
Sex
All
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Study 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 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.

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Conditions studied

  • Sepsis
  • Septic Shock
  • Sepsis Syndrome

Keywords

  • Immunophenotype
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In context

Sepsis

1,899 studies on the registry are indexed under Sepsis; 462 are open to participants now.

This study's planned enrollment of 200 is above the median of 160 across 931 observational studies indexed under Sepsis.

Browse Sepsis studies →

Lead sponsor

Southeast University, China is the lead sponsor of 164 studies on the registry; 44 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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 criteria

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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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (estimated)
Target follow-up
3 Months
Patient registry
Yes
Biospecimen retention
Samples without dna
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What researchers measure

Primary outcomes

  1. survival or death in 28 days

    observe wether the patients is 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

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Study locations

1 site
  • Department of Critical Care , Zhong-da Hospital
    Nanjing, Jiangsu 210009, China
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 2, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05602584
Lead sponsor
Southeast University, China
Responsible party
Jianfeng Xie (Clinical Professor, Southeast University, China) — Principal investigator
First posted
Nov 2, 2022
Start date
Oct 1, 2021
Primary completion
Oct 1, 2023 (estimated)
Completion
Dec 1, 2023 (estimated)
Last update
Nov 2, 2022

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.

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