Sepsis Clinical Trial
Official title:
Post Market Clinical Utility of ESId (MDW Hematology Parameter) for Early Sepsis Detection in the Emergency Department (US Hospitals) - Indiana University Hospital
NCT number | NCT04819035 |
Other study ID # | C54020 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | June 17, 2021 |
Est. completion date | May 30, 2022 |
Verified date | July 2022 |
Source | Beckman Coulter, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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).
Status | Completed |
Enrollment | 127 |
Est. completion date | May 30, 2022 |
Est. primary completion date | May 30, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 89 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Indiana University Methodist Hospital | Indianapolis | Indiana |
Lead Sponsor | Collaborator |
---|---|
Beckman Coulter, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Health & Economic Benefits for Hospital Stay - Simulated | 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 | |
Other | Health & Economic Benefits for Intensive Care Unit Stay - Simulated | 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 | |
Other | Health & Economic Benefits for Mortality - Simulated | 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 | |
Primary | Potential reduction of Time to Antibiotics Ordered and Administered | 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 | Performance | 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 |
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