Paramedics providing early treatment for severe sepsis in patients before hospital arrival

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

This study tests if giving early treatment for severe sepsis by paramedics before getting to the hospital can help patients survive better than the usual care they receive once they arrive.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 2040 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Sunnybrook Health Sciences Centre (Academic / other)
• Locations: 4 sites (Toronto, Ontario and 3 other locations)
• Trial ID: NCT03068741 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of paramedics administering early treatment for severe sepsis in out-of-hospital patients. It aims to determine if prompt recognition and treatment with antibiotics and intravenous fluids by paramedics can improve survival rates compared to standard care, which typically begins only after patients reach the emergency department. The study involves a randomized controlled trial design, comparing different treatment protocols in the field. The ultimate goal is to enhance the chain-of-survival for sepsis and potentially transform how sepsis care is delivered.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older who are suspected of having severe sepsis based on specific clinical criteria.

Not a fit: Patients with conditions such as cardiac arrest, severe trauma, or known allergies to study medications may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly increase survival rates for patients suffering from severe sepsis by reducing treatment delays.

How similar studies have performed: Other studies have suggested that early treatment for sepsis can improve outcomes, but this specific approach of paramedic intervention is relatively novel.

Eligibility 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. Known to be 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

Where this trial is running

Toronto, Ontario and 3 other locations

• Halton Region Paramedic Services — Toronto, Ontario, Canada (Recruiting)
• Peel Region Paramedic Services — Toronto, Ontario, Canada (Recruiting)
• Toronto Paramedic Services — Toronto, Ontario, Canada (Recruiting)
• York Region Paramedic Services — Toronto, Ontario, Canada (Recruiting)

Study contacts

• Principal investigator: Damon Scales, MD PhD FRCPC — Sunnybrook Health Sciences Centre
• Study coordinator: Damon Scales, MD PhD FRCPC

Conditions Severe Sepsis or Septic Shock