paramedic initiated treatment of sepsis targeting out-of-hospital patients (pitstop)

Conditions: Severe Sepsis or Septic Shock

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.

the ultimate goal of this research program is to evaluate a fundamental change in the delivery of sepsis care. currently, patients with severe sepsis do not receive key evidence-based therapies until they have been assessed in emergency departments - often introducing considerable delays. this research tests whether integrating paramedics directly into a chain-of-survival for sepsis will improve outcomes for these critically ill patients. in essence, this research seeks to break down silos of care, delivering sepsis treatments based on when they are needed, rather than on where the patient is physically located. if the trial is positive, the results will have broad implications for other health systems by showing that prehospital identification and treatment of sepsis increases the number of patients that survive this life-threatening condition. if the trial fails to demonstrate effectiveness of prehospital sepsis treatments, it will ensure that resources are not needlessly invested in large-scale implementations of paramedic sepsis protocols, as has been done in several other jurisdictions. a lack of benefit would also cast doubt on the observational data suggesting that early antibiotics are important, and suggest a more restrained approach to empiric antibiotic therapy.

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