NCT06541600

Brief Summary

This study will adopt a retrospective clinical cohort design and include a certain scale of sepsis patients as research objects to find the risk factors for adverse outcomes in patients with sepsis. Bioinformatics techniques were used to infer potential differential genes corresponding to different risk factors. Finally, through the biobank the investigators established in the past, biological samples of patients with sepsis were extracted and protein expression in the samples was detected to comprehensively analyze biological information at multiple levels.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10,313

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2003

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

January 1, 2003

Completed
20 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

May 6, 2024

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 7, 2024

Completed
Last Updated

August 7, 2024

Status Verified

August 1, 2024

Enrollment Period

20 years

First QC Date

May 6, 2024

Last Update Submit

August 2, 2024

Conditions

Keywords

sepsisSeptic cardiomyopathyKKS

Outcome Measures

Primary Outcomes (2)

  • Survival

    Survival

    28 days

  • Cardiac function

    Echocardiography (Ejection Fraction (EF))

    24 hours

Eligibility Criteria

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

Patients with sepsis

You may qualify if:

  • over 18 years old;
  • meet the diagnostic criteria for sepsis;
  • Duration of hospitalization: lasting more than 24 hours;
  • no important comorbidities, such as heart failure, liver and kidney insufficiency, malignant tumor, etc.
  • Antibiotic use: The time to start antibiotic treatment should not exceed 48 hours.

You may not qualify if:

  • less than 18 years old;
  • Clinical anti-infective therapy: Start long-term anti-infective therapy within 14 days before the expected time point of infection;
  • Duration of hospitalization: less than 24 hours;
  • The presence of other important complications, such as heart failure, liver and kidney insufficiency, and malignant tumors;
  • The presence of other important complications, such as heart failure, liver and kidney insufficiency, and malignant tumors;
  • The presence of other infectious diseases, such as tuberculosis, HIV/AIDS, etc.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

Location

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • QIN Zhang, phd

    Tongji Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 6, 2024

First Posted

August 7, 2024

Study Start

January 1, 2003

Primary Completion

January 1, 2023

Study Completion

January 1, 2023

Last Updated

August 7, 2024

Record last verified: 2024-08

Locations