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

Launched by DR. DAMON SCALES · Feb 24, 2017

Trial Information

Current as of July 21, 2025

Recruiting

Keywords

ClinConnect Summary

The PITSTOP trial is studying how early treatment for severe sepsis and septic shock can improve survival rates for patients before they even reach the hospital. Sepsis is a serious condition that can happen when an infection, often in the lungs, urinary system, or blood, causes the body to stop working properly. In this trial, paramedics will provide important treatments, like antibiotics and fluids, right at the scene, which may help patients get the care they need much faster compared to the usual process, where treatment usually starts once they arrive at the hospital.

To be eligible for this trial, participants must be at least 18 years old and show signs of sepsis, which means they have a suspected infection, a fever, and low blood pressure. However, some individuals, such as those who've recently had a heart attack or severe trauma, won't be able to participate. If enrolled, patients can expect to receive timely treatments from paramedics, which could significantly impact their recovery. This trial is currently recruiting participants, and it aims to determine if this early intervention can ultimately save more lives.

Gender

ALL

Eligibility criteria

  • 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

About Dr. Damon Scales

Dr. Damon Scales is a distinguished clinical trial sponsor with extensive expertise in the design and execution of innovative research studies. With a strong background in medical science and a commitment to advancing healthcare through rigorous clinical trials, Dr. Scales leads initiatives that prioritize patient safety and scientific integrity. His collaborative approach fosters partnerships with leading institutions and researchers, ensuring the delivery of high-quality data that supports the development of new therapies. Dedicated to enhancing clinical research methodologies, Dr. Scales is committed to contributing to the evolving landscape of medicine and improving patient outcomes.

Locations

Toronto, Ontario, Canada

Toronto, Ontario, Canada

Toronto, Ontario, Canada

Toronto, Ontario, Canada

Patients applied

0 patients applied

Trial Officials

Damon Scales, MD PhD FRCPC

Principal Investigator

Sunnybrook Health Sciences Centre

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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