NCT06068192

Brief Summary

1\) Establish a clinical data database for sepsis patients in the Emergency Department of the First Hospital of Jilin University. Describe the clinical data and prognosis of patients with simple systemic inflammatory response syndrome (common infection), pre sepsis, sepsis, and septic shock. 2) Explore the risk factors related to the progression of sepsis in patients in the early stages, as well as the risk factors related to the patient's prognosis. 3) Analyze the risk factors related to the prognosis of sepsis patients, and provide clinical basis for the treatment and long-term prognosis of sepsis patients. 4) Search for diagnostic biomarkers and prognostic serum biomarkers for patients with sepsis, sepsis, and septic shock.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
4mo left

Started Jan 2024

Typical duration for all trials

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress87%
Jan 2024Oct 2026

First Submitted

Initial submission to the registry

September 28, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 5, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2024

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

October 26, 2023

Status Verified

September 1, 2023

Enrollment Period

2.8 years

First QC Date

September 28, 2023

Last Update Submit

October 24, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • The patient dies within 28 days after hospitalization

    The patient dies within 28 days after hospitalization

    within 28 days after hospitalization

  • The patient does not die within 28 days after hospitalization

    The patient does not die within 28 days after hospitalization

    within 28 days after hospitalization

Study Arms (2)

28th day death group

Patient dies within 28 days after hospitalization

Other: no intervention

non-28th day death group

The patient does not die within 28 days after hospitalization

Other: no intervention

Interventions

no intervention

28th day death groupnon-28th day death group

Eligibility Criteria

Age15 Years+
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The study site and population included patients with systemic inflammatory response syndrome caused by "infectious factors" who were admitted to the Emergency Department of the First Hospital of Jilin University from January 1, 2023 to December 31, 2027. The screening criteria for the study population were patients with "systemic inflammatory response syndrome" caused by sensory factors who were continuously registered and treated at the Emergency Department of the First Affiliated Hospital of Jilin University from January 1, 2023 to December 31, 2027.

You may qualify if:

  • Age greater than or equal to 15 years old; 2) A patient who sought medical treatment at the Emergency Department of Jilin University First Hospital due to "systemic inflammatory response syndrome" (see relevant concepts and definitions in section 4.2 below). 3) Within 24 hours of seeking medical attention, evidence of "infection" can be clearly detected through imaging and laboratory examinations. Patients can be diagnosed and classified as at least one of the following conditions: respiratory system infection, digestive system infection, urinary system infection, blood borne infection, or skin soft tissue infection.

You may not qualify if:

  • pregnant and lactating women; 2) Active pulmonary tuberculosis; 3) Patients who do not agree to participate in this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood,urine and other infection sites to detect the pathogen.

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 28, 2023

First Posted

October 5, 2023

Study Start

January 1, 2024

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

October 26, 2023

Record last verified: 2023-09