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NCT04819035 · ClinicalTrials.gov registry record

Sepsis Post Market Clinical Utility Simple Endpoint Study - Indiana University Hospital

A clinical trial, sponsored by Beckman Coulter.

Completed
Registry status
127
Enrollment target

NCT04819035: Completed study, sponsored by Beckman Coulter.

NCT04819035 is a clinical trial that has completed, run by Beckman Coulter. The registered enrollment target is 127 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04819035 has completed, sponsored by Beckman Coulter.

COMPLETED
Registry status
127 participants
Enrollment target

Study 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 patients (simulated primary endpoint), with concomitant reductions in length of stay and in-hospital mortality for those patients (secondary endpoints).

Primary Outcome

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

Interventions

  • DIAGNOSTIC_TEST CBC-DIFF Monocyte Volume Width Distribution (MDW)

Trial Details

FieldValue
Enrollment Target 127 participants
Start Date 2021-06-17
Est. Completion 2022-05-30
Beckman Coulter

18 total trials

What the finished NCT04819035 record still lists

NCT04819035 is an observational study that tracks outcomes without assigning an intervention. The registered 127 participants enrollment target is mid-sized for trials with a published cap.

The record links to 0 conditions, and to 1 intervention - of which CBC-DIFF Monocyte Volume Width Distribution (MDW) is the first listed.

NCT04819035 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04819035 about?

NCT04819035 is a clinical study titled "Sepsis Post Market Clinical Utility Simple Endpoint Study - 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 presentatio...

What is the current status of trial NCT04819035?

This trial is currently completed. The enrollment target is 127 participants. The study started on 2021-06-17. Estimated completion is 2022-05-30.

What interventions are being tested in trial NCT04819035?

The interventions under investigation include: CBC-DIFF Monocyte Volume Width Distribution (MDW) (DIAGNOSTIC_TEST).

Who is sponsoring clinical trial NCT04819035?

This trial is sponsored by Beckman Coulter, which has 18 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT04819035, the US trial registry maintained by the National Library of Medicine. NCT04819035 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.