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Completed

NCT Number: NCT03068741

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Halton Region Paramedic Services, Toronto, Ontario, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • Known to be 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

Treatment and study plan

Comparison 1: Prehospital Ceftriaxone

Drug

Paramedics will administer 1g of intramuscular ceftriaxone.

Other names: Ceftriaxone

Comparison 1: Placebo

Drug

Paramedics will administer an identical volume of reconstituted intramuscular placebo.

Other names: 0.9% saline for injection

Comparison 2: Liberal fluids

Drug

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.

Other names: intravenous saline (0.9%) for injection

Comparison 2: Conservative fluids

Drug

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.

Other names: intravenous saline (0.9%) for injection

Primary outcomes

  1. Primary outcome: mortality prior to hospital discharge to day 90.

    Time frame: 90 days

    Dichotomous outcome reported as percentage

Secondary outcomes

  1. Mortality at 90 days after enrollment

    Time frame: 90 days after enrollment

    Dichotomous outcome reported as percentage

  2. Organ dysfunction during first 24 hours (mechanical ventilation, vasopressor therapy (any), dialysis

    Time frame: 24 hours

    Dichotomous outcome reported as percentage

  3. Organ dysfunction during hospitalization (mechanical ventilation)

    Time frame: until hospital discharge, measured up to maximum of day 90

    Dichotomous outcome reported as percentage

  4. duration of hospital admission (if any)

    Time frame: until hospital discharge, measured up to maximum of day 90

    Measured in days from time of randomization

  5. duration of first ICU admission (if any)

    Time frame: until ICU discharge, measured up to maximum of day 90

    Measured in days from time of randomization

  6. Proportion of patients with positive blood cultures obtained in hospital

    Time frame: 24 hours

    Dichotomous outcome reported as percentage

  7. Microbiology results (if any)

    Time frame: 24 hours

    Descriptive outcome, reported as frequency distribution of positive culture results

  8. Proportion of patients receiving antibiotics within first 24 hours of hospitalization

    Time frame: 24 hours

    Dichotomous outcome reported as percentage

  9. Frequency distribution and mean time to first dose of antibiotics (if any) within first 24 hours of hospitalization

    Time frame: 24 hours

    Measured in hours from time of randomization

  10. Proportion of patients receiving IV fluids (>250mL) within first 24 hours of hospitalization

    Time frame: 24 hours

    measured in milliliters

  11. Total amount of IV fluids administered during transport and first 24 hours of hospitalization (if any)

    Time frame: 24 hours

    measured in milliliters

  12. Proportion of patients with pulmonary edema identified during transport to hospital and on initial chest x-ray

    Time frame: during transport and on initial chest x-ray (if completed)

    Dichotomous outcome reported as percentage

  13. Proportion of patients with blood, urine, sputum cultures that grow organisms resistant to ceftriaxone

    Time frame: 24 hours

    Dichotomous outcome reported as percentage

  14. Proportion of patients diagnosed with sepsis or infection by emergency department physician

    Time frame: during admission

    Dichotomous outcome reported as percentage

  15. Proportion of hospitalized patients who grow any antibiotic-resistant organism (methicilin resistant S. aureus, Clostridium difficile, extended beta-lactamase resistant organisms)

    Time frame: during admission

    Dichotomous outcome reported as percentage

  16. Proportion of patients with anaphylaxis or suspected allergic reactions to study medication

    Time frame: during admission

    Dichotomous outcome reported as percentage

Sponsors and collaborators

Lead sponsor

Dr. Damon Scales

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)
  • Sunnybrook Research Institute

Registry information

Acronym: PITSTOP

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Mar 3, 2017
Registry last updated
Apr 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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