Effect of Immunophenotype on Prognosis of Sepsis

October 29, 2022 updated by: Jianfeng Xie, Southeast University, China

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.

Study Overview

Status

Enrolling by invitation

Conditions

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 Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210009
        • Department of Critical Care , Zhong-da Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Southeast University, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2021

Primary Completion (Anticipated)

October 1, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

July 2, 2022

First Submitted That Met QC Criteria

October 29, 2022

First Posted (Actual)

November 2, 2022

Study Record Updates

Last Update Posted (Actual)

November 2, 2022

Last Update Submitted That Met QC Criteria

October 29, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EOIPOPOS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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