Field Paramedic Application of Sepsis Triage

Sepsis Clinical Trial

— FAST  

Official title:

Field Paramedic Application of Sepsis Triage

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03870789
• Other study ID #: 3075-C
• Status: Recruiting
• Start date: December 11, 2016
• Est. completion date: December 31, 2019

Study information

• Verified date: March 2019
• Source: Hamilton Health Sciences Corporation
• Contact: Natasha Clayton, CRA, RA
• Phone: 905-521-2100
• Email: clayton[@]mcmaster.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 31, 2019
• Est. primary completion date: May 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Sepsis
• Toxemia

Locations

Country	Name	City	State
Canada	Centre for Paramedic Education and Research, Hamilton Health Sciences	Hamilton	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Hamilton Health Sciences Corporation	Hamilton Academic Health Sciences Organization

Country where clinical trial is conducted

Canada, 

References & Publications (3)

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. — View Citation

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

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy of HEWS	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.	1 year
Secondary	Evaluate the addtion of end-tidal carbon dioxide (ETCO2) values	To evaluate the addition of ETCO2 values to predict mortality in patients who screen positive for sepsis.	1 year
Secondary	Evaluate sepsis alert program	To identify the before and after healthcare outcomes of a prehospital sepsis alert program.	2 years