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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
IMPRESS Trial 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.Check my eligibility
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.See study design
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.
IMPRESS Trial 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)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Time to First Antibiotic Administration in the ED
Secondary outcome measures
Antibiotic Days of Therapy
EMS Documentation of Sepsis
Septicemia
+6 moreIMPRESS 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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Who is running the clinical trial?
Centers for Disease Control and PreventionFED
875 Previous Clinical Trials
22,476,402 Total Patients Enrolled
6 Trials studying Sepsis
62,293 Patients Enrolled for Sepsis
Emory UniversityLead Sponsor
1,638 Previous Clinical Trials
2,559,532 Total Patients Enrolled
13 Trials studying Sepsis
10,247 Patients Enrolled for Sepsis
Carmen C Polito, MD, MScPrincipal InvestigatorEmory University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am over 40, have had a fever or low blood pressure, or needed oxygen.
Research Study Groups:
This trial has the following groups:- Group 1: PRESS Intervention
- Group 2: Standard of Care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this research program accept new participants?
"The clinicaltrials.gov website indicates that this trial, which was posted on December 1st 2022 and last updated October 11th 2022, is not currently recruiting participants. Despite this, 169 other studies are actively looking for volunteers to take part in their research endeavors."
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