Paramedic Initiated Treatment of Sepsis Targeting Out-of-hospital Patients (PITSTOP) (PITSTOP)
Severe Sepsis or Septic Shock
About this trial
This is an interventional treatment trial for Severe Sepsis or Septic Shock
Eligibility Criteria
Inclusion Criteria:
- 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
- Age ≥ 18 years
Exclusion Criteria:
- Post cardiac arrest
- Suspected ST-segment elevation myocardial infarction (STEMI)
- Suspected acute cerebrovascular accident (CVA)
- Acute severe trauma
- Obvious severe non-traumatic bleeding
- Signs of fluid overload
- Suspected acute congestive heart failure (CHF)
- Known Clostridium difficile infection within the last 6 weeks
- Known pregnancy or breastfeeding
- Known allergy or sensitivity to penicillin or cephalosporin
- Receiving oral or subcutaneous anticoagulants or low molecular weight heparin
- Paramedic is unable to identify patient by first and last name and/or health card number
Sites / Locations
- Halton Region Paramedic ServicesRecruiting
- Peel Region Paramedic ServicesRecruiting
- Toronto Paramedic ServicesRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Active Comparator
Placebo Comparator
Experimental
Active Comparator
Comparison 1: Prehospital Ceftriaxone
Comparison 1: Placebo
Comparison 2: Liberal fluids
Comparison 2: Conservative fluids
1g of Ceftriaxone will be administered by immediate intramuscular (IM) injection. The drug is provided in a sterile and completely covered vial as a white, odourless powder
The placebo is provided in a sterile and completely covered vial.
Paramedics will administer up to 2 litres of intravenous 0.9% saline solution to all participants in this arm regardless of blood pressure, reassessing for signs of volume overload after each 250ml.
Paramedics will administer 0.9% saline solution to participants who have systolic blood pressure <90mmHg, and will only continue the infusion until the systolic blood pressure is >=100mmHg.