Host Dysregulation-Driven Sepsis Prediction Model

October 29, 2024 updated by: Second Affiliated Hospital of Wenzhou Medical University

Construction and Validation of a Sepsis Prediction Model Based on Dysregulation of Host Response

The aim of this study is to identify risk factors associated with sepsis and to construct a predictive model for sepsis. This will provide an objective theoretical and empirical foundation for the diagnosis, assessment, and management of sepsis in our country.The primary questions addressed are:

What are the risk factors for the development of sepsis? How do we improve the prognosis of sepsis?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1000

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
    • Zhejiang
      • Wenzhou, Zhejiang, China, 325027
        • The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University,
      • Wenzhou, Zhejiang, China, 325000
        • Xiue Ye

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

Patients with Infection or Suspected Infection

Description

Inclusion Criteria:

  • Patients with Infection or Suspected Infection

Exclusion Criteria:

  • Patients with Autoimmune Diseases
  • Pregnant Women
  • Patients with Advanced-Stage Cancer and Systemic Metastasis

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Sepsis Group
Other: Tumor Necrosis Factor
This study is a retrospective observational study, with Tumor Necrosis Factor being one of the exposure factors under investigation.
Other: Interleukin-1β
This study is a retrospective observational study, with Interleukin-1β being one of the exposure factors under investigation.
Other: Interleukin-12
This study is a retrospective observational study, with Interleukin-12 being one of the exposure factors under investigation.
Other: Interleukin-18
This study is a retrospective observational study, with Interleukin-18 being one of the exposure factors under investigation.
Other: Complement C3
This study is a retrospective observational study, with Complement C3 being one of the exposure factors under investigation.
Other: Complement C5
This study is a retrospective observational study, with Complement C5 being one of the exposure factors under investigation.
Non-Sepsis Group
Other: Tumor Necrosis Factor
This study is a retrospective observational study, with Tumor Necrosis Factor being one of the exposure factors under investigation.
Other: Interleukin-1β
This study is a retrospective observational study, with Interleukin-1β being one of the exposure factors under investigation.
Other: Interleukin-12
This study is a retrospective observational study, with Interleukin-12 being one of the exposure factors under investigation.
Other: Interleukin-18
This study is a retrospective observational study, with Interleukin-18 being one of the exposure factors under investigation.
Other: Complement C3
This study is a retrospective observational study, with Complement C3 being one of the exposure factors under investigation.
Other: Complement C5
This study is a retrospective observational study, with Complement C5 being one of the exposure factors under investigation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sepsis
Time Frame: 3 months
A rapid increase of 2 or more points points in the Sequential Organ Failure Assessment (SOFA) score after patient infection.SOFA score, which ranges from a minimum of 2 to a maximum of 15, indicates a worse outcome with higher scores.
3 months

Collaborators and Investigators

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

Sponsor

Second Affiliated Hospital of Wenzhou Medical University

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)

September 1, 2024

Primary Completion (Actual)

October 13, 2024

Study Completion (Actual)

October 17, 2024

Study Registration Dates

First Submitted

July 14, 2024

First Submitted That Met QC Criteria

July 22, 2024

First Posted (Actual)

July 26, 2024

Study Record Updates

Last Update Posted (Actual)

October 31, 2024

Last Update Submitted That Met QC Criteria

October 29, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SAHoWMU-CR2024-16-214

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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