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

• Status: Recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dr. Damon Scales
• Collaborators: Canadian Institutes of Health Research (CIHR); Sunnybrook Research Institute
• Treatments: Ceftriaxone

Criteria

Inclusion Criteria:

1. Patients with Sepsis, defined as (all 3 must be present): i) Paramedic suspects possible infection: e.g. suspected pneumonia, urinary tractinfection, skin infection, bone and joint infection, intra-abdominal infection, meningitis ii) Presence of fever: Temperature ≥ 38.0°C 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 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