- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04819035
Sepsis Post Market Clinical Utility Simple Endpoint Study - Indiana University Hospital
July 15, 2022 updated by: Beckman Coulter, Inc.
Post Market Clinical Utility of ESId (MDW Hematology Parameter) for Early Sepsis Detection in the Emergency Department (US Hospitals) - Indiana University Hospital
The purpose of this study is to demonstrate that addition of the Monocyte Width Distribution (MDW) parameter to current standard of care improves a clinician's ability to recognize sepsis in the Emergency Department, resulting in earlier decision to administer antibiotics from time of ED presentation for sepsis patients (simulated primary endpoint), with concomitant reductions in length of stay and in-hospital mortality for those patients (secondary endpoints).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The objective of this study is to develop a method for identifying sepsis patients from electronic health records (EHR) based on Sepsis-2 criteria.
Sepsis patients will be identified using a Sepsis Definition which includes meeting SIRS score of ≥2 within 12 hours of ED presentation and any microbial testing ordered within 24 hours of ED presentation.
The patient will be enrolled if it meets the Sepsis Definition and additional EMR data elements will be extracted to complete case report form.
Furthermore, objectives include to confirm the clinical validity and performance of MDW in a control population of sepsis patients where MDW is measured but not reported to physicians.
This study is an observational study which will simulate the decision impact of MDW on sepsis identification and patient management
Study Type
Observational
Enrollment (Actual)
127
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Indiana
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Indianapolis, Indiana, United States, 46202
- Indiana University Methodist Hospital
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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
18 years to 89 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
All adult patients presenting to the ED where a CBC-Diff has been ordered by standard of care
Description
Inclusion Criteria:
- Adult (18 to 89 years)
- All race and ethnicities
- Presenting to the emergency department with suspicion of infection
- Whose assessment includes a CBC with differential
- Meets EMR Sepsis Definition
Exclusion Criteria:
- Pregnancy
- Prisoners
- Transfers from other ED
- Previously enrolled
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 |
---|---|
CBC-Diff Monocyte Volume Width Distribution
Monocyte Volume Width Distribution (MDW) is part of the CBC with Differential
|
MDW measurement will be used to detect sepsis.
Results will not be used to manage patients.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Potential reduction of Time to Antibiotics Ordered and Administered
Time Frame: Within 12 hours from presentation to the emergency department
|
Monocyte Distribution Width's [MDW] ability to reduce time to first antibiotics ordered by physician (decision to treat) and first antibiotics administered via a simulation
|
Within 12 hours from presentation to the emergency department
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Performance
Time Frame: Within 12 hours from presentation to the emergency department
|
Monocyte Distribution Width's [MDW] ability to identify Sepsis vs Non-Sepsis when using a Sepsis electronic medical record definition using AUC (Area Under The Curve) ROC (Receiver Operating Characteristics) curve.
|
Within 12 hours from presentation to the emergency department
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Health & Economic Benefits for Hospital Stay - Simulated
Time Frame: Within 12 hours from presentation to the emergency department
|
Monocyte Distribution Width's [MDW] ability to reduce length of hospital stay by earlier detection of sepsis by using AUC (Area Under The Curve) ROC (Receiver Operating Characteristics) curve.
|
Within 12 hours from presentation to the emergency department
|
Health & Economic Benefits for Intensive Care Unit Stay - Simulated
Time Frame: Within 12 hours from presentation to the emergency department
|
Monocyte Distribution Width's [MDW] ability to reduce length of intensive care unit stay by earlier detection of sepsis by using AUC (Area Under The Curve) ROC (Receiver Operating Characteristics) curve.
|
Within 12 hours from presentation to the emergency department
|
Health & Economic Benefits for Mortality - Simulated
Time Frame: Within 12 hours from presentation to the emergency department
|
Monocyte Distribution Width's [MDW] ability to reduce in-house mortality by earlier detection of sepsis by using AUC (Area Under The Curve) ROC (Receiver Operating Characteristics) curve.
|
Within 12 hours from presentation to the emergency department
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Magdalena Czader, MD, Indiana University Health
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)
June 17, 2021
Primary Completion (ACTUAL)
May 30, 2022
Study Completion (ACTUAL)
May 30, 2022
Study Registration Dates
First Submitted
March 24, 2021
First Submitted That Met QC Criteria
March 25, 2021
First Posted (ACTUAL)
March 26, 2021
Study Record Updates
Last Update Posted (ACTUAL)
July 18, 2022
Last Update Submitted That Met QC Criteria
July 15, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- C54020
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
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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