NCT05602584

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2021

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

July 2, 2022

Completed
4 months until next milestone

First Posted

Study publicly available on registry

November 2, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

November 2, 2022

Status Verified

October 1, 2022

Enrollment Period

2 years

First QC Date

July 2, 2022

Last Update Submit

October 29, 2022

Conditions

Keywords

Immunophenotype

Outcome Measures

Primary Outcomes (1)

  • survival or death in 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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Critical Care , Zhong-da Hospital

Nanjing, Jiangsu, 210009, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Peripheral blood of patients with sepsis was collected on day 1, 3, 7, 14 and 28

MeSH Terms

Conditions

SepsisShock, SepticSystemic Inflammatory Response Syndrome

Condition Hierarchy (Ancestors)

InfectionsInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

July 2, 2022

First Posted

November 2, 2022

Study Start

October 1, 2021

Primary Completion

October 1, 2023

Study Completion

December 1, 2023

Last Updated

November 2, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations