Clinical trial NCT03870789: Field Paramedic Application of Sepsis Triage
Official title: Field Paramedic Application of Sepsis Triage
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sepsis
Keywords: sepsis, septic shock, early warning scores, infecion
Lead sponsor: Hamilton Health Sciences Corporation
Sponsor class: OTHER
Collaborators: name: Hamilton Academic Health Sciences Organization
First posted: 2019-03-12
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with suspected infection.

Brief summary: 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: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Accuracy of HEWS
timeFrame: 1 year
Secondary outcomes:
measure: Evaluate the addtion of end-tidal carbon dioxide (ETCO2) values
timeFrame: 1 year
measure: Evaluate sepsis alert program
timeFrame: 2 years
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Centre for Paramedic Education and Research, Hamilton Health Sciences
state: Ontario
Study officials:
affiliation: Hamilton Health Sciences Corporation
name: Michelle Wellsford, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Canadian Institute for Health Information. In Focus: A National Look at Sepsis.; 2009. https://secure.cihi.ca/free_products/HSMR_Sepsis2009_e.pdf.
citation: 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.