NCT02232750

Brief Summary

The investigators hypothesize that CPD parameters will provide improved prediction of sepsis compared to currently employed laboratory parameters. These studies hold the potential to shape practitioner guidelines and improve the timeliness and accuracy with which patients with sepsis are treated today.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,320

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 14, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 26, 2014

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 5, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2015

Completed
Last Updated

November 3, 2021

Status Verified

November 1, 2021

Enrollment Period

1.1 years

First QC Date

August 26, 2014

Last Update Submit

November 1, 2021

Conditions

Sepsis, Severe Sepsis and Septic Shock

Outcome Measures

Primary Outcomes (1)

  • We are measuring CBC (complete blood count) and MNV (Mean Neutrophil Volume)

    Evaluate the clinical utility of CPD MNV as an aid in the diagnosis and risk assessment of Emergency Department patients for progression to sepsis, severe sepsis and septic shock.

    approximately 10 months

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Emergency Department

You may qualify if:

  • Adult (≥18 to 90 years)
  • Patients presenting to the Emergency Department
  • CBC (Complete Blood Count) with differential testing performed and CPD data retrieved

You may not qualify if:

  • Previously enrolled in this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wexner Medical Center at The Ohio State University

Columbus, Ohio, 43210, United States

Location

Related Publications (1)

  • Crouser ED, Parrillo JE, Seymour C, Angus DC, Bicking K, Tejidor L, Magari R, Careaga D, Williams J, Closser DR, Samoszuk M, Herren L, Robart E, Chaves F. Improved Early Detection of Sepsis in the ED With a Novel Monocyte Distribution Width Biomarker. Chest. 2017 Sep;152(3):518-526. doi: 10.1016/j.chest.2017.05.039. Epub 2017 Jun 15.

    PMID: 28625579DERIVED

MeSH Terms

Conditions

SepsisShock, Septic

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Director, Intensive Care Unit

Study Record Dates

First Submitted

August 26, 2014

First Posted

September 5, 2014

Study Start

July 14, 2014

Primary Completion

August 15, 2015

Study Completion

August 15, 2015

Last Updated

November 3, 2021

Record last verified: 2021-11

Locations

US(1)