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Paramedic Initiated Treatment of Sepsis Targeting Out-of-hospital Patients (PITSTOP)

Severe Sepsis or Septic Shock

Sepsis occurs when a serious infection - most commonly infection of the lungs, urinary system, or blood - leads to acute organ failure. It is a common, expensive, and frequently lethal condition. A growing body of evidence suggests that early recognition and treatment of sepsis can improve survival.

Unfortunately, many patients with sepsis do not receive key therapies until physicians working in Emergency Departments have assessed them - often introducing marked delays. It is estimated that one-half of patients with sepsis are treated and transported to hospital by paramedics. This allows paramedics a unique opportunity to provide early treatment at the initial point of patient contact, thereby decreasing the time to treatment for these critically ill patients. This randomized controlled trial will evaluate whether prompt recognition followed by early antibiotics and/or intravenous fluids delivered by paramedics in the field leads to improved survival, compared to usual care, for patients who are transported to the hospital with sepsis.

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Participation Requirements

  • Sex:

    ALL

  • Eligible Ages:

    18 and up

Participation Criteria

Inclusion Criteria:

1. Patients with Sepsis, defined as (all 3 must be present): i) Paramedic suspects possible infection: e.g. suspected pneumonia, urinary tract infection, skin infection, bone and joint infection, intra-abdominal infection, meningitis ii) Presence of fever: Temperature ≥ 38.0°C measured by paramedic or history of fever during previous 24 hours iii) Presence of hypotension: Systolic blood pressure \< 100mmHg
2. Age ≥ 18 years

Exclusion Criteria:

1. Post cardiac arrest
2. Suspected ST-segment elevation myocardial infarction (STEMI)
3. Suspected acute cerebrovascular accident (CVA)
4. Acute severe trauma
5. Obvious severe non-traumatic bleeding
6. Signs of fluid overload
7. Suspected acute congestive heart failure (CHF)
8. Known Clostridium difficile infection within the last 6 weeks
9. Known pregnancy or breastfeeding
10. Known allergy or sensitivity to penicillin or cephalosporin
11. Receiving oral or subcutaneous anticoagulants or low molecular weight heparin
12. Paramedic is unable to identify patient by first and last name and/or health card number

Study Location

York Region Paramedic Services
York Region Paramedic Services
Toronto, Ontario
Canada

Contact Study Team

Primary Contact

Chief Chris Spearen

Toronto Paramedic Services
Toronto Paramedic Services
Toronto, Ontario
Canada

Contact Study Team

Primary Contact

Chief Bikram Chawla

Peel Region Paramedic Services
Peel Region Paramedic Services
Toronto, Ontario
Canada

Contact Study Team

Primary Contact

Chief Peter Dundas

Halton Region Paramedic Services
Halton Region Paramedic Services
Toronto, Ontario
Canada

Contact Study Team

Primary Contact

Chief Greg Sage

Study Sponsored By
Sunnybrook Health Sciences Centre
Participants Required
More Information
Study ID: NCT03068741