Host Dysregulation-Driven Sepsis Prediction Model

Completed

• Conditions: Sepsis
• Interventions: Other: Tumor Necrosis Factor; Other: Interleukin-1β; Other: Interleukin-12; Other: Interleukin-18; Other: Complement C3; Other: Complement C5

• Registration Number: NCT06523075
• Lead Sponsor: Second Affiliated Hospital of Wenzhou Medical University

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?

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-07-14
• Study First Submitted QC: 2024-07-22
• Study First Posted: 2024-07-26
• Study Start: 2024-09-01
• Status Verified: 2024-10
• Primary Completion: 2024-10-13
• Study Completion: 2024-10-17
• Last Update Submitted: 2024-10-29
• Last Update Posted: 2024-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Non-Sepsis Group	Complement C5	-
Sepsis Group	Tumor Necrosis Factor	-
Sepsis Group	Interleukin-12	-
Sepsis Group	Complement C3	-
Sepsis Group	Complement C5	-
Non-Sepsis Group	Interleukin-1β	-
Non-Sepsis Group	Complement C3	-
Non-Sepsis Group	Tumor Necrosis Factor	-
Sepsis Group	Interleukin-1β	-
Sepsis Group	Interleukin-18	-
Non-Sepsis Group	Interleukin-12	-
Non-Sepsis Group	Interleukin-18	-

Primary Outcome Measures

Name	Time	Method
Sepsis	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.

Trial Locations

Locations (2)

Xiue Ye; 🇨🇳 Wenzhou, Zhejiang, China

The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University,; 🇨🇳 Wenzhou, Zhejiang, China