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

PHASE4Active, not recruitingINTERVENTIONAL
Enrollment

2,040

Participants

Timeline

Start Date

March 23, 2020

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2025

Conditions
Severe Sepsis or Septic Shock
Interventions
DRUG

Comparison 1: Prehospital Ceftriaxone

Paramedics will administer 1g of intramuscular ceftriaxone.

DRUG

Comparison 1: Placebo

Paramedics will administer an identical volume of reconstituted intramuscular placebo.

DRUG

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.

DRUG

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.

Trial Locations (4)

Unknown

Halton Region Paramedic Services, Toronto

Peel Region Paramedic Services, Toronto

Toronto Paramedic Services, Toronto

York Region Paramedic Services, Toronto

All Listed Sponsors
collaborator

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

collaborator

Sunnybrook Research Institute

OTHER

lead

Dr. Damon Scales

OTHER