NCT05309889

Brief Summary

Sepsis is a life-threatening organ dysfunction caused by a dysregulated host response to infection and is associated with high morbidity and mortality. Sepsis3 gives sepsis a broad definition, reflecting the heterogeneity of the disease. So we need a precise treatment with a stratification of patient prognosis in order to reduce mortality in patients with 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
174

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2022

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 30, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 4, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

May 12, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

May 31, 2022

Status Verified

March 1, 2022

Enrollment Period

12 months

First QC Date

March 30, 2022

Last Update Submit

May 25, 2022

Conditions

Sepsis

Outcome Measures

Primary Outcomes (1)

  • mortality rate

    all-cause deaths that occurred in 28 days

    28 days after diagnosis of sepsis

Study Arms (2)

high exposure level

Patients have a high level of exposure factors

Other: no intervention

low exposure level

Patients have a low level of exposure factors

Other: no intervention

Interventions

no interventionOTHER

no intervention

high exposure levellow exposure level

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who were hospitalized in the ICU of Sun Yat-sen Memorial Hospital of Sun Yat-sen University and met the Sepsis 3 diagnostic criteria.

You may qualify if:

  • Patients who met the Sepsis3 diagnostic criteria.

You may not qualify if:

  • Absence of laboratory test items (blood routine examination, coagulation function, liver function, biochemistry, urine routine examination, urine renal function, urine protein, etc.) \>20%.
  • Admission in ICU less than 48 hours.
  • Patient with psychiatric disorders.
  • Under 18 years of age.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Guangzhou, China

RECRUITING

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Yuewei Li

CONTACT

020-81332587liyw7@mail2.sysu.edu.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2022

First Posted

April 4, 2022

Study Start

May 12, 2022

Primary Completion

May 1, 2023

Study Completion

June 1, 2023

Last Updated

May 31, 2022

Record last verified: 2022-03

Locations

CN(1)