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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
2,040
Paramedics will administer 1g of intramuscular ceftriaxone.
Paramedics will administer an identical volume of reconstituted intramuscular placebo.
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.
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.
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
Primary outcome: mortality prior to hospital discharge to day 90.
Dichotomous outcome reported as percentage
Time frame: 90 days
Mortality at 90 days after enrollment
Dichotomous outcome reported as percentage
Time frame: 90 days after enrollment
Organ dysfunction during first 24 hours (mechanical ventilation, vasopressor therapy (any), dialysis
Dichotomous outcome reported as percentage
Time frame: 24 hours
Organ dysfunction during hospitalization (mechanical ventilation)
Dichotomous outcome reported as percentage
Time frame: until hospital discharge, measured up to maximum of day 90
duration of hospital admission (if any)
Measured in days from time of randomization
Time frame: until hospital discharge, measured up to maximum of day 90
duration of first ICU admission (if any)
Measured in days from time of randomization
Time frame: until ICU discharge, measured up to maximum of day 90
Proportion of patients with positive blood cultures obtained in hospital
Dichotomous outcome reported as percentage
Time frame: 24 hours
Microbiology results (if any)
Descriptive outcome, reported as frequency distribution of positive culture results
Time frame: 24 hours
Proportion of patients receiving antibiotics within first 24 hours of hospitalization
Dichotomous outcome reported as percentage
Time frame: 24 hours
Frequency distribution and mean time to first dose of antibiotics (if any) within first 24 hours of hospitalization
Measured in hours from time of randomization
Time frame: 24 hours
Proportion of patients receiving IV fluids (>250mL) within first 24 hours of hospitalization
measured in milliliters
Time frame: 24 hours
Total amount of IV fluids administered during transport and first 24 hours of hospitalization (if any)
measured in milliliters
Time frame: 24 hours
Proportion of patients with pulmonary edema identified during transport to hospital and on initial chest x-ray
Dichotomous outcome reported as percentage
Time frame: during transport and on initial chest x-ray (if completed)
Proportion of patients with blood, urine, sputum cultures that grow organisms resistant to ceftriaxone
Dichotomous outcome reported as percentage
Time frame: 24 hours
Proportion of patients diagnosed with sepsis or infection by emergency department physician
Dichotomous outcome reported as percentage
Time frame: during admission
Proportion of hospitalized patients who grow any antibiotic-resistant organism (methicilin resistant S. aureus, Clostridium difficile, extended beta-lactamase resistant organisms)
Dichotomous outcome reported as percentage
Time frame: during admission
Proportion of patients with anaphylaxis or suspected allergic reactions to study medication
Dichotomous outcome reported as percentage
Time frame: during admission
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