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

Severe Sepsis or Septic Shock Clinical Trial

— PITSTOP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03068741
• Other study ID #: The PITSTOP RCT
• Status: Recruiting
• Phase: Phase 4
• Start date: March 23, 2020
• Est. completion date: December 2025

Study information

• Verified date: March 2024
• Source: Sunnybrook Health Sciences Centre
• Contact: Damon Scales, MD PhD FRCPC
• Phone: 416-480-5291
• Email: damon.scales[@]sunnybrook.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2040
• Est. completion date: December 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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. 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

Related Conditions & MeSH terms

• Sepsis
• Severe Sepsis or Septic Shock
• Toxemia

Intervention

Drug:
• Comparison 1: Prehospital Ceftriaxone
Paramedics will administer 1g of intramuscular ceftriaxone.
• Comparison 1: Placebo
Paramedics will administer an identical volume of reconstituted intramuscular placebo.
• 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.
• 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.

Locations

Country	Name	City	State
Canada	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

Sponsors (3)

Lead Sponsor	Collaborator
Dr. Damon Scales	Canadian Institutes of Health Research (CIHR), Sunnybrook Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

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