- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05088850
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
- Name: Ranran Li, PhD
- Phone Number: 18317059746
- Email: rebecca1009@hotmail.com
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 200025
- Recruiting
- ICU, Ruijin Hospital
-
Contact:
- Ranran Li, PhD
- Phone Number: 18317059746
- Email: rebecca1009@hotmail.com
-
-
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:
- At least 14 years old.
- Sepsis onset at least 5 hours after ICU admission.
- 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:
- At least 14 years old.
- Patients staying in ICU for at least 5 hours and have not had sepsis in this time.
- Patients without ICD-9 codes for sepsis (785·52, 995·91, 995·92).
- 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
|
no intervention
|
non-sepsis
|
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
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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