Host Dysregulation-Driven Sepsis Prediction Model

NCT06523075 — Completed, 1000 participants, Second Affiliated Hospital of Wenzhou Medical University

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

Registry	NCT06523075
Status	Completed
Study type	Observational
Enrollment	1000 (Actual)
Sponsor	Second Affiliated Hospital of Wenzhou Medical University (Other)
Conditions	Sepsis
Interventions	Tumor Necrosis Factor, Interleukin-1β, Interleukin-12, Interleukin-18, Complement C3, Complement C5 (Other)
Dates	start 2024-09-01, primary completion 2024-10-13, completion 2024-10-17, first posted 2024-07-26, last updated 2024-10-31
Locations	2 sites in China

-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?

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+Arms and interventions

Arm	Type	Interventions	Description
Sepsis Group		Other: Tumor Necrosis Factor; Other: Interleukin-1β; Other: Interleukin-12; Other: Interleukin-18; Other: Complement C3; Other: Complement C5
Non-Sepsis Group		Other: Tumor Necrosis Factor; Other: Interleukin-1β; Other: Interleukin-12; Other: Interleukin-18; Other: Complement C3; Other: Complement C5

Tumor Necrosis Factor (Other): This study is a retrospective observational study, with Tumor Necrosis Factor being one of the exposure factors under investigation.
Interleukin-1β (Other): This study is a retrospective observational study, with Interleukin-1β being one of the exposure factors under investigation.
Interleukin-12 (Other): This study is a retrospective observational study, with Interleukin-12 being one of the exposure factors under investigation.
Interleukin-18 (Other): This study is a retrospective observational study, with Interleukin-18 being one of the exposure factors under investigation.
Complement C3 (Other): This study is a retrospective observational study, with Complement C3 being one of the exposure factors under investigation.
Complement C5 (Other): This study is a retrospective observational study, with Complement C5 being one of the exposure factors under investigation.

+Outcome measures

Primary outcomes

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.

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Patients with Infection or Suspected Infection

Exclusion Criteria:

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

+Locations (2)

Facility	City	Country	Status
Xiue Ye	Wenzhou, Zhejiang	China
The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University,	Wenzhou, Zhejiang	China