Early Identification and Prognosis Prediction of Sepsis Through Multiomics

Recruiting

• Conditions: Sepsis

• Registration Number: NCT05305469
• Lead Sponsor: Yantai Yuhuangding Hospital

Brief Summary

This study aims to integrate multi-omics data and clinical indicators to reveal pathogen-specific molecular patterns in patients with sepsis and establish prognostic prediction models through multiple machine learning algorithms.

Detailed Description

This study aims to quantify the plasma metabolome, single nucleotide polymorphisms (SNPs) of exons and immunocytokines of septic patients with different pathogen infections and prognostic outcomes. Multi-omics data, cytokines, and clinical indicators will be integrated through multiple machine learning algorithms to reveal pathogen-specific molecular patterns and multi-dimensional prognostic prediction models.

Study Timeline

• Study Start: 2022-01-01
• Study First Submitted: 2022-03-22
• Study First Submitted QC: 2022-03-22
• Study First Posted: 2022-03-31
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-22
• Last Update Posted: 2024-01-24
• Primary Completion: 2024-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 900

Inclusion Criteria

• Patients with sepsis or septic shock who meet the diagnostic criteria (2016 sepsis 3.0 standard);
• Age 18～85 years old.

Exclusion Criteria

• ICU stay of the subjects less than 72 hours;
• Female subjects who are pregnant;
• The subjects not sure if infected;
• The subjects performed CPR;
• The subjects suffer from chronic renal disease;
• The subjects with incomplete clinical data.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pathogen-specific patterns	March 2022 - December 2023	To elucidate the unique infection pathogen-specific molecular patterns in septic patients

Secondary Outcome Measures

Name	Time	Method
Prognostic prediction models	March 2022 - December 2024	To establish the models using multi-omics data to predict the prognosis of sepsis

Trial Locations

Locations (1)

Yantai Yuhuangding Hospital; 🇨🇳 Yantai, Shandong, China