Mathematical Modeling and Risk Factor Analysis for Mortality of Sepsis

Mathematical Modeling and Risk Factor Analysis for Mortality of Sepsis Based on Real World Data in China

The purpose of this study was to investigate the risk factors for mortality of sepsis and to create mathematical models to predict the survival rate based on electronic health records that extracted from hospital information system. More than 1000 records should be collected and used to data analysis. Univariate and multivariable logistic regression model were applied to risk factors analysis for the outcome, and machine learn algorithms were employed to generate predictive models for the outcome.

Study Overview

• Status: Unknown
• Conditions: Morality; Predictive Model; Risk Factor, Sepsis
• Intervention / Treatment: Other: regular medical treatment

• Study Type: Observational
• Enrollment (Anticipated): 2000

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • Recruiting
    • Zihui Tang
    • Contact: Zihui Tang, Dr; Phone Number: 021 15821993541; Email: albert.tang@163.com
    • Principal Investigator: Yu Lu, Dr
    • Principal Investigator: Zihui Tang, Dr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 99 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

all patients with sepsis in emergence department of hospitals

Description

Inclusion Criteria:

• all records with sepsis in emergence department of hospitals

Exclusion Criteria:

• subjects with major missing data

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
mortality of sepsis; the study sample would be extracted from electronic health records in emergence departments. risk factor analysis and mathematical modeling would be performed to evaluate the significant and independent risk factors and predictive models.	Other: regular medical treatment; regular medical treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mortality of sepsis	mortality of sepsis	4 weeks

Collaborators and Investigators

• Sponsor: Shanghai Tongji Hospital, Tongji University School of Medicine
• Collaborators: Department of Emergence, The First Hospital Affiliated to South China University, Hengyang, Hunan, China.; Department of Integrative Medicine, Huashan Hospital of Fudan University, Shanghai, China; Department of Biomedical Informatics and Statistics, Insitute of Integrative Medicine, Fudan University, Shanghai, China; Department of emergence, Hunan people's hospital, Changhai, Hunan, China; Department of emergence, The hospital affiliated to Jining medical college, Jining, Shandong, China; Department of emergence, Huaihua people's hospital, Huaihua, Hunan, China

Publications and helpful links

General Publications

• Lu Y, Tang ZH, Zeng F, Li Y, Zhou L. The association and predictive value analysis of metabolic syndrome combined with resting heart rate on cardiovascular autonomic neuropathy in the general Chinese population. Diabetol Metab Syndr. 2013 Nov 17;5(1):73. doi: 10.1186/1758-5996-5-73.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): March 1, 2019
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: March 19, 2019
• First Submitted That Met QC Criteria: March 19, 2019
• First Posted (Actual): March 20, 2019

Study Record Updates

• Last Update Posted (Actual): January 6, 2021
• Last Update Submitted That Met QC Criteria: January 5, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Toxemia
• Other Study ID Numbers: 20190319

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No