NCT06523075

Brief Summary

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?

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2024

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

July 14, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 26, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 13, 2024

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 17, 2024

Completed
Last Updated

October 31, 2024

Status Verified

October 1, 2024

Enrollment Period

1 month

First QC Date

July 14, 2024

Last Update Submit

October 29, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Sepsis

    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

Study Arms (2)

Sepsis Group

Other: Tumor Necrosis FactorOther: Interleukin-1βOther: Interleukin-12Other: Interleukin-18Other: Complement C3Other: Complement C5

Non-Sepsis Group

Other: Tumor Necrosis FactorOther: Interleukin-1βOther: Interleukin-12Other: Interleukin-18Other: Complement C3Other: Complement C5

Interventions

This study is a retrospective observational study, with Tumor Necrosis Factor being one of the exposure factors under investigation.

Non-Sepsis GroupSepsis Group

This study is a retrospective observational study, with Interleukin-1β being one of the exposure factors under investigation.

Non-Sepsis GroupSepsis Group

This study is a retrospective observational study, with Interleukin-12 being one of the exposure factors under investigation.

Non-Sepsis GroupSepsis Group

This study is a retrospective observational study, with Interleukin-18 being one of the exposure factors under investigation.

Non-Sepsis GroupSepsis Group

This study is a retrospective observational study, with Complement C3 being one of the exposure factors under investigation.

Non-Sepsis GroupSepsis Group

This study is a retrospective observational study, with Complement C5 being one of the exposure factors under investigation.

Non-Sepsis GroupSepsis Group

Eligibility Criteria

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

Patients with Infection or Suspected Infection

You may qualify if:

  • Patients with Infection or Suspected Infection

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Xiue Ye

Wenzhou, Zhejiang, 325000, China

Location

The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University,

Wenzhou, Zhejiang, 325027, China

Location

MeSH Terms

Conditions

Sepsis

Interventions

Tumor Necrosis Factor-alphaInterleukin-12Interleukin-18Complement C3Complement C5

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

GlycoproteinsGlycoconjugatesCarbohydratesMonokinesCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsTumor Necrosis FactorsBlood ProteinsProteinsBiological FactorsInterleukinsAcute-Phase ProteinsComplement System ProteinsImmunoproteins

Study Design

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

Study Record Dates

First Submitted

July 14, 2024

First Posted

July 26, 2024

Study Start

September 1, 2024

Primary Completion

October 13, 2024

Study Completion

October 17, 2024

Last Updated

October 31, 2024

Record last verified: 2024-10

Locations