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Paramedic Initiated Treatment of Sepsis Targeting Out-of-hospital Patients (PITSTOP)
Sponsor: Dr. Damon Scales
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
2040
Start Date
2020-03-23
Completion Date
2025-12
Last Updated
2025-09-11
Healthy Volunteers
No
Conditions
Interventions
Comparison 1: Prehospital Ceftriaxone
Paramedics will administer 1g of intramuscular ceftriaxone.
Comparison 1: Placebo
Paramedics will administer an identical volume of reconstituted intramuscular placebo.
Comparison 2: Liberal fluids
Paramedics will administer up to 2 litres of intravenous saline (0.9%) to all patients regardless of systolic blood pressure, and reassessing this infusion after each 250ml are infused.
Comparison 2: Conservative fluids
Paramedics will administer intravenous saline (0.9%) according to the Medical Directive, which allows for infusion of fluids if systolic blood pressure is \<90mmHg and continued until systolic blood pressure is \>=100mmHg.
Locations (4)
Halton Region Paramedic Services
Toronto, Ontario, Canada
Peel Region Paramedic Services
Toronto, Ontario, Canada
Toronto Paramedic Services
Toronto, Ontario, Canada
York Region Paramedic Services
Toronto, Ontario, Canada