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

Phase 4

Recruiting

• Conditions: Severe Sepsis or Septic Shock

• Registration Number: NCT03068741
• Lead Sponsor: Dr. Damon Scales

Brief 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.

Detailed Description

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 Timeline

• Study First Submitted: 2017-02-06
• Study First Submitted QC: 2017-02-24
• Study First Posted: 2017-03-03
• Study Start: 2020-03-23
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-27
• Last Update Posted: 2025-03-04
• Primary Completion: 2025-08
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2040

Inclusion Criteria

1. 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
2. Age ≥ 18 years

Exclusion Criteria

1. Post cardiac arrest
2. Suspected ST-segment elevation myocardial infarction (STEMI)
3. Suspected acute cerebrovascular accident (CVA)
4. Acute severe trauma
5. Obvious severe non-traumatic bleeding
6. Signs of fluid overload
7. Suspected acute congestive heart failure (CHF)
8. Known Clostridium difficile infection within the last 6 weeks
9. Known pregnancy or breastfeeding
10. Known allergy or sensitivity to penicillin or cephalosporin
11. Known to be receiving oral or subcutaneous anticoagulants or low molecular weight heparin
12. Paramedic is unable to identify patient by first and last name and/or health card number

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Primary outcome: mortality prior to hospital discharge to day 90.	90 days	Dichotomous outcome reported as percentage

Secondary Outcome Measures

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

Trial Locations

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