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Prehospital Sepsis Protocol for Sepsis (IMPRESS Trial)

N/A

Recruiting

Led By Carmen C Polito, MD, MSc

Research Sponsored by Emory University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up during hospital stay (up to 20 days, on average)

Awards & highlights

No Placebo-Only Group

Summary

This trial will test if an emergency medical services (EMS) based sepsis screening and early warning protocol can improve the timing of sepsis care in the emergency department (ED).

Who is the study for?

This trial is for adults who have signs of sepsis, like a fast pulse rate over 90 bpm, low blood pressure under 110 mmHg, or rapid breathing over 20 breaths per minute. They must be transported by EMS to a participating hospital and meet other criteria such as being aged 40+, having a high temperature or low oxygen levels. Pregnant individuals and those with trauma, cardiac arrest, psychiatric emergencies or toxic ingestion are excluded.

What is being tested?

The study tests the 'PRESS Intervention', which is an early warning protocol used by emergency services to identify and start treatment for sepsis before reaching the hospital. The goal is to see if this prehospital procedure can speed up care once patients arrive at the Emergency Department.

What are the potential side effects?

Since this trial focuses on improving response times rather than testing new medications, it does not directly involve side effects from interventions. However, there may be risks associated with delayed or accelerated medical procedures.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ during hospital stay (up to 20 days, on average)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~during hospital stay (up to 20 days, on average)

This trial's timeline: 3 weeks for screening, Varies for treatment, and during hospital stay (up to 20 days, on average) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Time to First Antibiotic Administration in the ED

Secondary study objectives

Antibiotic Days of Therapy

EMS Documentation of Sepsis

Septicemia

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: PRESS InterventionExperimental Treatment1 Intervention

Study sites will participate in the intervention phase for 6 to 18 months, depending on the order of cluster randomization. Sites will switch from the baseline phase in approximately 6 month blocks, with all sites delivering the intervention for the final 6 months of the study.

Group II: Standard of CareActive Control1 Intervention

Study sites will participate in the standard of care phase to collect baseline data for 6 to 18 months, depending on the order of cluster randomization. All sites are in the baseline phase for the first 6 months then sites will switch one at a time, every 6 months, to the intervention phase of the study.

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