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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

2040 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-23

Study Completion Date

2025-12-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Severe Sepsis or Septic Shock

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

This is a 2x2 factorial RCT, with simultaneous randomization of individual patients into 2 randomized controlled trials.

The first RCT compares administration of 1g of intramuscular ceftriaxone versus placebo. In this RCT, participants, care providers, investigators, and outcome assessors will all be masked to the treatment allocation.

The second RCT compares a liberal fluid resuscitation (up to 2litres of intravenous 0.9% saline) versus conventional resuscitation (administration of intravenous 0.9% saline, started only when systolic blood pressure is \<90mmHg and only continued until systolic blood pressure is \>= 100mmHg). In this RCT, only participants and outcome assessors will be masked.

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

The study drug and placebo are prepared in identical masked containers.

Study Groups

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Comparison 1: Prehospital Ceftriaxone

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

Group Type ACTIVE_COMPARATOR

Comparison 1: Prehospital Ceftriaxone

Intervention Type DRUG

Paramedics will administer 1g of intramuscular ceftriaxone.

Comparison 1: Placebo

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

Group Type PLACEBO_COMPARATOR

Comparison 1: Placebo

Intervention Type DRUG

Paramedics will administer an identical volume of reconstituted intramuscular placebo.

Comparison 2: Liberal fluids

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.

Group Type EXPERIMENTAL

Comparison 2: Liberal fluids

Intervention Type 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.

Comparison 2: Conservative fluids

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.

Group Type ACTIVE_COMPARATOR

Comparison 2: Conservative fluids

Intervention Type 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.

Interventions

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Comparison 1: Prehospital Ceftriaxone

Paramedics will administer 1g of intramuscular ceftriaxone.

Intervention Type DRUG

Comparison 1: Placebo

Paramedics will administer an identical volume of reconstituted intramuscular placebo.

Intervention Type DRUG

Comparison 2: Liberal fluids

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.

Intervention Type DRUG

Comparison 2: Conservative fluids

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.

Intervention Type DRUG

Other Intervention Names

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Ceftriaxone 0.9% saline for injection intravenous saline (0.9%) for injection intravenous saline (0.9%) for injection

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No