The Early Prediction of Sepsis in ICU

October 19, 2021 updated by: lei li, Ruijin Hospital

The Early Prediction of Sepsis Occurrence in ICU

Sepsis is a vital issue in critical care medicine, and early detection and intervention are key to survival. We aimed to establish an early warning system for sepsis based on a data integration platform that can be implemented in the ICU.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200025

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients that were admitted into the ICU.

Description

Inclusion Criteria:

Patients who met all of the following criteria were included in the case group:

  1. At least 14 years old.
  2. Sepsis onset at least 5 hours after ICU admission.
  3. Sepsis onset is the first instance since admission to the hospital.

Exclusion Criteria:

Patients meeting all of the following criteria were included in the control group:

  1. At least 14 years old.
  2. Patients staying in ICU for at least 5 hours and have not had sepsis in this time.
  3. Patients without ICD-9 codes for sepsis (785·52, 995·91, 995·92).
  4. SOFA score change is not more than 1 point in an arbitrary continuous 72 hours in the ICU stay.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
sepsis
Other: no intervention
no intervention
non-sepsis
Other: no intervention
no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
confidence index of sepsis occurrence
Time Frame: sepsis occurrence in five hours
sepsis occurrence in five hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ruijin Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 30, 2020

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

October 18, 2021

First Submitted That Met QC Criteria

October 19, 2021

First Posted (Actual)

October 22, 2021

Study Record Updates

Last Update Posted (Actual)

October 22, 2021

Last Update Submitted That Met QC Criteria

October 19, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20211014LILEI

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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