NCT04771429

Brief Summary

Timely and accurately predicting the occurrence of sepsis and actively intervening in treatment may effectively improve the survival and cure rate of patients with sepsis. Using machine learning and natural language processing, we want to develop models to 1) identify all children with sepsis admitted to hospital and 2) stratify them to distinguish those who are at high risk of death b) How will you undertake your work? From Shanghai hospitals anf MIMIC III, we will develop a very large dataset of patient admissions for all medical conditions including sepsis from the electronic health record. This data will include both structured data such as age, gender, medications, laboratory values, co-morbidities as well as unstructured data such as discharge summaries and physician notes. Using the dataset, we will train a model through natural language processing and machine learning to be able to identify people admitted with sepsis and identify those patients who will be at high risk of death. We will test the ability of these models to determine our predictive accuracies. We will then test these models at other institutions.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
4,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2019

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

February 24, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 25, 2021

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2021

Completed
Last Updated

February 25, 2021

Status Verified

February 1, 2021

Enrollment Period

1.9 years

First QC Date

February 24, 2021

Last Update Submit

February 24, 2021

Conditions

Keywords

sepsis prediction, machine learning, mix interpolation

Outcome Measures

Primary Outcomes (1)

  • Identification of sepsis

    Sepsis patients were screened based on the Sepsis-III standard

    Baseline

Eligibility Criteria

Age1 Year - 18 Years
Sexall(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

For data analysis in winter 2021, we have access to sepsis data up to February 2016 to July 2018.

You may qualify if:

  • diagnosed with "infection", "septic shock" or "sepsis" or "septicemia"

You may not qualify if:

  • Acute upper respiratory tract infection
  • Newborns

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China

Shanghai, Yangpu, 200092, China

RECRUITING

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Xin Sun, MD

    Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 24, 2021

First Posted

February 25, 2021

Study Start

April 1, 2019

Primary Completion

March 1, 2021

Study Completion

April 1, 2021

Last Updated

February 25, 2021

Record last verified: 2021-02

Locations