SepsisNCT04804306
Sepsis Post Market Clinical Utility Simple Endpoint Study - HUMC
An observational study of Sepsis and Adult Disease, run by Beckman Coulter, Inc. at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 19 to 89 years
- Conditions the study is for
- Sepsis, Adult Disease, Emergency Department
- What is being tested?
- Diagnostic Test: CBC-DIFF Monocyte Volume Width Distribution (MDW)
- Type of treatment
- Medical device
- How many people
- 198 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Sep 2021to 6 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 89 years
- All sexes
- Adult, Older adult
Study population: All adult patients presenting to the ED where a CBC-Diff has been ordered by standard of care
Who may be able to join
- 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
Who cannot join
- Pregnancy
- Prisoners
- Transfers from other ED
- Previously enrolled
Trial locations and contacts
1 site in 1 country.
United States1 site
Hackensack University Medical Center
Hackensack, New Jersey, 07601
About this study
Official title: Post Market Clinical Utility of ESId (MDW Hematology Parameter) for Early Sepsis Detection in the Emergency Department (US Hospitals) - Hackensack University Medical Center
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).
Read the 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.
- Conditions
- Sepsis, Adult Disease, Emergency Department, Severe Sepsis
- Being tested
- Diagnostic Test: CBC-DIFF Monocyte Volume Width Distribution (MDW)
- Medical subject headings
- Sepsis, Disease, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic Test: CBC-DIFF Monocyte Volume Width Distribution (MDW)Device
MDW measurement used to detect sepsis. Results will not be used to manage patients.
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic Test: CBC-Diff Monocyte Volume Width Distribution | MDW measurement used to detect sepsis as part of the CBC-Diff ordered by ED Physician as part of the Institution's Standard of Care. Results will not be used to manage patients Receives: Device: Diagnostic Test: CBC-DIFF Monocyte Volume Width Distribution (MDW) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Potential reduction of Time to Antibiotics
MDW's ability to reduce time to first antibiotics ordered by physician (decision to treat)-Simulated
Measured: Within 12 hours from presentation to the emergency department
Secondary outcomes (1)
Performance
MDW's ability to identify Sepsis vs Non-Sepsis when using a Sepsis electronic medical record definition
Measured: Within 12 hours from presentation to the emergency department
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2021
- Study start5 Sep 2021
- Primary completion6 Jun 2022
- Study completion6 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beckman Coulter, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joseph Parrillo, MD, Principal investigator, Hackensack Meridian HealthKeri Bicking, PharmD, Principal investigator, Hackensack Meridian Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04804306
- Sponsor's protocol ID
- C01238
- Status last verified
- Jul 2022
- First submitted
- 11 Mar 2021
- Last updated
- 18 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Market Clinical Utility of ESId (MDW Hematology Parameter) for Early Sepsis Detection in the Emergency Department (US Hospitals) - Hackensack University Medical Center
- ClinicalTrials.gov ID
- NCT04804306
- Acronym / sponsor ID
- C01238
- Conditions
- Sepsis, Adult Disease, Emergency Department, Severe Sepsis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- Beckman Coulter, Inc.Industry (pharma, biotech, devices)
- Study start
- 5 Sep 2021 (actual)
- Primary completion
- 6 Jun 2022 (actual)
- Study completion
- 6 Jun 2022 (actual)
- First posted
- 18 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic Test: CBC-Diff Monocyte Volume Width Distribution | – | Device: Diagnostic Test: CBC-DIFF Monocyte Volume Width Distribution (MDW)MDW measurement used to detect sepsis as part of the CBC-Diff ordered by ED Physician as part of the Institution's Standard of Care. Results will not be used to manage patients |
Who may qualify
- Ages
- 19 to 89 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All adult patients presenting to the ED where a CBC-Diff has been ordered by standard of care
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Pregnancy
- Prisoners
- Transfers from other ED
- Previously enrolled
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diagnostic Test: CBC-DIFF Monocyte Volume Width Distribution (MDW)MDW measurement used to detect sepsis. Results will not be used to manage patients. | Device | Diagnostic Test: CBC-Diff Monocyte Volume Width Distribution |
Primary outcome
Potential reduction of Time to Antibiotics
Time frame: Within 12 hours from presentation to the emergency department
MDW's ability to reduce time to first antibiotics ordered by physician (decision to treat)-Simulated
1 secondary outcome
Performance
Time frame: Within 12 hours from presentation to the emergency department
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph Parrillo, MD principal investigator
Hackensack Meridian Health
Keri Bicking, PharmD principal investigator
Hackensack Meridian Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Adult Disease, run by Beckman Coulter, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Potential reduction of Time to Antibiotics (time frame: Within 12 hours from presentation to the emergency department). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2022.