Improving early sepsis care through EMS screening
A Multicenter, Stepped Wedge, Cluster Randomized Study of a Prehospital Sepsis Protocol and Its Impact on Timely Antibiotic Administration in the Emergency Department and Subsequent Adverse Events
NA · Emory University · NCT05502107
This study tests a new way for emergency medical teams to spot sepsis early and alert the hospital so patients can get antibiotics faster and have better outcomes.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Emory University (other) |
| Locations | 3 sites (Atlanta, Georgia and 2 other locations) |
| Trial ID | NCT05502107 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of a prehospital sepsis screening and early warning protocol implemented by Emergency Medical Services (EMS) to enhance the timely administration of antibiotics and improve patient outcomes in the Emergency Department (ED). The PRESS protocol combines a validated sepsis screening tool with an alert system to notify the ED of potential sepsis cases before patient arrival. By operationalizing this protocol, the study aims to minimize delays in sepsis recognition and treatment, addressing a critical gap in emergency care for this life-threatening condition.
Who should consider this trial
Good fit: Ideal candidates for this study include patients with low blood pressure, high pulse and respiratory rates, and other indicators of sepsis who are transported by EMS to participating hospitals.
Not a fit: Patients with trauma injuries, cardiac arrest, psychiatric emergencies, or those who are pregnant will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the time to treatment for sepsis, potentially improving survival rates and outcomes for patients.
How similar studies have performed: Previous studies have shown success with similar prehospital screening protocols in other time-sensitive medical emergencies, suggesting a promising potential for this approach in sepsis care.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Lowest EMS systolic blood pressure \<110 mmHg * Highest EMS pulse rate \>90 beats per minute * Highest EMS respiratory rate \>20 breaths per minute * EMS transport to a participating study ED/hospital * At least one of the following present: * Lowest systolic blood pressure \<90 mmHg * Age 40 years or greater * Hot temperature assessment or temp \>38 degrees Celsius * Oxygen saturation \<90% * Nursing home patient * Emergency Medical Dispatch classification = 'sick person' Exclusion Criteria: * Any of the following EMS conditions present: * Trauma injury * Cardiac arrest * Psychiatric emergency * Toxic ingestion * Pregnant patient * Inability to administratively link EMS and ED/hospital records * Patient left emergency department prior to being evaluated by a medical provider (inability to classify sepsis status)
Where this trial is running
Atlanta, Georgia and 2 other locations
- Emory University Hospital — Atlanta, Georgia, United States (RECRUITING)
- University of Iowa — Iowa City, Iowa, United States (RECRUITING)
- Washington University — Saint Louis, Missouri, United States (RECRUITING)
Study contacts
- Principal investigator: Carmen C Polito, MD, MSc — Emory University
- Study coordinator: Carmen C Polito, MD, MSc
- Email: cpolito@emory.edu
- Phone: 404-616-4891
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Sepsis, Sepsis screening, EMS-based screening