Comparison 1: Prehospital Ceftriaxone
DrugParamedics will administer 1g of intramuscular ceftriaxone.
Other names: Ceftriaxone
NCT Number: NCT03068741
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Phase 4
Halton Region Paramedic Services, Toronto, Ontario, Canada
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Paramedics will administer 1g of intramuscular ceftriaxone.
Other names: Ceftriaxone
Paramedics will administer an identical volume of reconstituted intramuscular placebo.
Other names: 0.9% saline for injection
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.
Other names: intravenous saline (0.9%) for injection
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.
Other names: intravenous saline (0.9%) for injection
Time frame: 90 days
Dichotomous outcome reported as percentage
Time frame: 90 days after enrollment
Dichotomous outcome reported as percentage
Time frame: 24 hours
Dichotomous outcome reported as percentage
Time frame: until hospital discharge, measured up to maximum of day 90
Dichotomous outcome reported as percentage
Time frame: until hospital discharge, measured up to maximum of day 90
Measured in days from time of randomization
Time frame: until ICU discharge, measured up to maximum of day 90
Measured in days from time of randomization
Time frame: 24 hours
Dichotomous outcome reported as percentage
Time frame: 24 hours
Descriptive outcome, reported as frequency distribution of positive culture results
Time frame: 24 hours
Dichotomous outcome reported as percentage
Time frame: 24 hours
Measured in hours from time of randomization
Time frame: 24 hours
measured in milliliters
Time frame: 24 hours
measured in milliliters
Time frame: during transport and on initial chest x-ray (if completed)
Dichotomous outcome reported as percentage
Time frame: 24 hours
Dichotomous outcome reported as percentage
Time frame: during admission
Dichotomous outcome reported as percentage
Time frame: during admission
Dichotomous outcome reported as percentage
Time frame: during admission
Dichotomous outcome reported as percentage
Dr. Damon Scales
Other
Acronym: PITSTOP
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT03682003
Infections, Inflammation
Rennes, France
View Trial DetailsNCT02656654
Fluid Resuscitation, Infections
Chalon-sur-Saône, France
View Trial DetailsNCT01689441
Infections, Inflammation
Boston, Massachusetts, United States
View Trial DetailsNCT01845766
Behavior, Infections
Seoul, South Korea
View Trial Details