Field Paramedic Application of Sepsis Triage

NCT ID: NCT03870789

Last Updated: 2019-03-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-12-11

Study Completion Date

2019-12-31

Brief Summary

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Given the implementation of the Hamilton Early Warning Score (HEWS) and the use of capnography by paramedics, this study will involve a large multi-site retrospective evaluation (before vs after implementation) of the HEWS score and comparison of the HEWS to systemic inflammatory response syndrome (SIRS), quick Sepsis Related Organ failure Assessment (qSOFA) and Modified Early Warning Score (MEWS) when applied retrospectively for the identification of sepsis in the prehospital setting.

Detailed Description

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1. To determine the accuracy of the HEWS score, compared to qSOFA, and SIRS for early sepsis recognition when used in the prehospital setting by paramedics for the identification of patients with sepsis or suspected sepsis.
2. To evaluate the addition of ETCO2 values to predict mortality in patients who screen positive for sepsis.
3. To identify the before and after healthcare outcomes of a prehospital sepsis alert program.

Conditions

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Sepsis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Retrospective

The Investigators will examine data from 1-year prior to paramedic implementation of the Hamilton Early Warning Score tool.

No interventions assigned to this group

Prospective

The Investigators will examine data from 1-year after paramedic implementation of the Hamilton Early Warning Score tool.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

Any patient to which paramedics apply the Hamilton Early Warning Score or patients who arrive to the Emergency Department (ED) by ambulance without a pre-alert and meet the definition of sepsis in the ED will also be included, and patient is ≥ 18 years

Exclusion Criteria

Patient is an inter-facility transfer, or patients with absent vital signs are absent, or death before blood can be drawn in the Emergency Department, or the patient fits the criteria for another prehospital alert (ST-elevation myocardial infarction, cerebrovascular vascular accident, or trauma)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hamilton Academic Health Sciences Organization

OTHER

Sponsor Role collaborator

Hamilton Health Sciences Corporation

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michelle Wellsford, MD

Role: PRINCIPAL_INVESTIGATOR

Hamilton Health Sciences Corporation

Locations

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Centre for Paramedic Education and Research, Hamilton Health Sciences

Hamilton, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Natasha Clayton, CRA, RA

Role: CONTACT

905-521-2100 ext. 44832

Facility Contacts

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Natasha Clayton, CRA, RA

Role: primary

References

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Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287.

Reference Type BACKGROUND
PMID: 26903338 (View on PubMed)

Canadian Institute for Health Information. In Focus: A National Look at Sepsis.; 2009. https://secure.cihi.ca/free_products/HSMR_Sepsis2009_e.pdf.

Reference Type BACKGROUND

Angus DC, Linde-Zwirble WT, Lidicker J, Clermont G, Carcillo J, Pinsky MR. Epidemiology of severe sepsis in the United States: analysis of incidence, outcome, and associated costs of care. Crit Care Med. 2001 Jul;29(7):1303-10. doi: 10.1097/00003246-200107000-00002.

Reference Type BACKGROUND
PMID: 11445675 (View on PubMed)

Other Identifiers

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3075-C

Identifier Type: -

Identifier Source: org_study_id

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