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

  • STATUS
    Recruiting
  • End date
    Dec 24, 2024
  • participants needed
    2040
  • sponsor
    Dr. Damon Scales
Updated on 5 March 2022

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.

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.

Details
Condition Severe Sepsis or Septic Shock
Treatment Comparison 1: Prehospital Ceftriaxone, Comparison 1: Placebo, Comparison 2: Liberal fluids, Comparison 2: Conservative fluids
Clinical Study IdentifierNCT03068741
SponsorDr. Damon Scales
Last Modified on5 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients with Sepsis, defined as (all 3 must be present): i) Paramedic suspects possible infection: e.g. suspected pneumonia, urinary tractinfection, skin infection, bone and joint infection, intra-abdominal infection, meningitis ii) Presence of fever: Temperature 38.0C 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 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
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
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