SepsisFASTNCT03870789
Field Paramedic Application of Sepsis Triage
An observational study of Sepsis, run by Hamilton Health Sciences Corporation at 1 site in Canada.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis
- How many people
- 400 participants
- Where
- 1 siteCanada
- Study dates
- 11 Dec 2016to 31 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with suspected infection.
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Centre for Paramedic Education and Research, Hamilton Health Sciences
Hamilton, Ontario, L8E 5E3
Natasha Clayton, CRA, RA
About this study
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.
Read the detailed description
- 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.
- To evaluate the addition of ETCO2 values to predict mortality in patients who screen positive for sepsis.
- To identify the before and after healthcare outcomes of a prehospital sepsis alert program.
- Conditions
- Sepsis
- Keywords
- sepsis, septic shock, early warning scores, infecion
- Medical subject headings
- Sepsis, Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Retrospective | The Investigators will examine data from 1-year prior to paramedic implementation of the Hamilton Early Warning Score tool. | |
| Prospective | The Investigators will examine data from 1-year after paramedic implementation of the Hamilton Early Warning Score tool. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (2)
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.
Measured: 1 year
Evaluate sepsis alert program
To identify the before and after healthcare outcomes of a prehospital sepsis alert program.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2019
- Study start11 Dec 2016
- Primary completion1 May 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Collaborators
- Hamilton Academic Health Sciences Organization
- Responsible party
- Sponsor
- Investigators
- Michelle Wellsford, MD, Principal investigator, Hamilton Health Sciences Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03870789
- Sponsor's protocol ID
- 3075-C
- Acronym
- FAST
- Status last verified
- Mar 2019
- First submitted
- 8 Mar 2019
- Last updated
- 12 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 26903338Canadian Institute for Health Information. In Focus: A National Look at Sepsis.; 2009. https://secure.cihi.ca/free_products/HSMR_Sepsis2009_e.pdf.
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.
PubMed 11445675
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Field Paramedic Application of Sepsis Triage
- ClinicalTrials.gov ID
- NCT03870789
- Acronym / sponsor ID
- FAST / 3075-C
- Conditions
- Sepsis
- Keywords
- sepsis, septic shock, early warning scores, infecion
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Collaborators
- Hamilton Academic Health Sciences Organization
- Study start
- 11 Dec 2016 (actual)
- Primary completion
- 1 May 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 12 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
- To evaluate the addition of ETCO2 values to predict mortality in patients who screen positive for sepsis.
- To identify the before and after healthcare outcomes of a prehospital sepsis alert program.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retrospective | – | –The Investigators will examine data from 1-year prior to paramedic implementation of the Hamilton Early Warning Score tool. |
| Prospective | – | –The Investigators will examine data from 1-year after paramedic implementation of the Hamilton Early Warning Score tool. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with suspected infection.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Accuracy of HEWS
Time frame: 1 year
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 secondary outcomes
Evaluate the addtion of end-tidal carbon dioxide (ETCO2) values
Time frame: 1 year
Evaluate sepsis alert program
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2019.
- Background: PubMed 26903338Singer 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.
- BackgroundCanadian Institute for Health Information. In Focus: A National Look at Sepsis.; 2009. https://secure.cihi.ca/free_products/HSMR_Sepsis2009_e.pdf.
- Background: PubMed 11445675Angus 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.
Related trials for Sepsis
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michelle Wellsford, MD principal investigator
Hamilton Health Sciences Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis, run by Hamilton Health Sciences Corporation at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Natasha Clayton, CRA, RA (905-521-2100 ext. 44832, clayton@mcmaster.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of HEWS (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03870789, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2019.