Early Identification and Prognosis Prediction of Sepsis Through Multiomics

Sepsis Clinical Trial

— EIPPSM  

Official title:

Early Identification and Prognosis Prediction of Sepsis Through Multiomics

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05305469
• Other study ID #: 2022-031
• Status: Recruiting
• Start date: January 1, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: January 2024
• Source: Yantai Yuhuangding Hospital
• Contact: Jing Wang
• Phone: 8605356691999
• Email: wangjinghehe[@]sina.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 900
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Sepsis
• Toxemia

Locations

Country	Name	City	State
China	Yantai Yuhuangding Hospital	Yantai	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Yantai Yuhuangding Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

Wang J, Sun Y, Teng S, Li K. Prediction of sepsis mortality using metabolite biomarkers in the blood: a meta-analysis of death-related pathways and prospective validation. BMC Med. 2020 Apr 15;18(1):83. doi: 10.1186/s12916-020-01546-5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pathogen-specific patterns	To elucidate the unique infection pathogen-specific molecular patterns in septic patients	March 2022 - December 2023
Secondary	Prognostic prediction models	To establish the models using multi-omics data to predict the prognosis of sepsis	March 2022 - December 2024