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

Dr. Damon Scales

Status and phase: Enrolling; Phase 4

Conditions: Severe Sepsis or Septic Shock

Treatments: Drug: Comparison 1: Prehospital Ceftriaxone; Drug: Comparison 2: Liberal fluids; Drug: Comparison 1: Placebo; Drug: Comparison 2: Conservative fluids

Study type: Interventional

Funder types: Other

Identifiers

NCT03068741

The PITSTOP RCT

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,040 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

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2,040 participants in 4 patient groups, including a placebo group

Comparison 1: Prehospital Ceftriaxone

Active Comparator group

Description:

1g of Ceftriaxone will be administered by immediate intramuscular (IM) injection. The drug is provided in a sterile and completely covered vial as a white, odourless powder

Treatment:

Drug: Comparison 1: Prehospital Ceftriaxone

Comparison 1: Placebo

Placebo Comparator group

Description:

The placebo is provided in a sterile and completely covered vial.

Treatment:

Drug: Comparison 1: Placebo

Comparison 2: Liberal fluids

Experimental group

Description:

Paramedics will administer up to 2 litres of intravenous 0.9% saline solution to all participants in this arm regardless of blood pressure, reassessing for signs of volume overload after each 250ml.

Treatment:

Drug: Comparison 2: Liberal fluids

Comparison 2: Conservative fluids

Active Comparator group

Description:

Paramedics will administer 0.9% saline solution to participants who have systolic blood pressure \<90mmHg, and will only continue the infusion until the systolic blood pressure is \>=100mmHg.

Treatment:

Drug: Comparison 2: Conservative fluids