1000 Participants Needed

Prehospital Sepsis Protocol for Sepsis

(IMPRESS Trial)

Recruiting at 2 trial locations
CC
JE
Overseen ByJonathan E Sevransky, MD, MHS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Emory University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the PRESS Intervention treatment for sepsis?

The PRESS Intervention treatment aims to improve early recognition of sepsis by emergency medical services (EMS), which is crucial for better outcomes. Studies show that using specific protocols and screening tools in prehospital settings can enhance the identification of sepsis, potentially leading to timely and effective treatment.12345

Is the PRESS Intervention for sepsis safe for humans?

The PRESS Intervention is a protocol to help recognize sepsis early, but there is no specific safety data available for this treatment in the provided research articles.16789

How does the Prehospital Sepsis Protocol treatment differ from other sepsis treatments?

The Prehospital Sepsis Protocol is unique because it focuses on early recognition and management of sepsis by emergency medical services (EMS) before reaching the hospital. It involves a screening tool that uses specific criteria and measurements, like end-tidal carbon dioxide, to identify sepsis early, which is different from traditional hospital-based treatments that start after diagnosis.13101112

What is the purpose of this trial?

The primary purpose of this study is to evaluate the impact of an Emergency Medical Services (EMS) based sepsis screening and early warning protocol on the timing of early sepsis care in the Emergency Department (ED).

Research Team

CC

Carmen C Polito, MD, MSc

Principal Investigator

Emory University

JE

Jonathan E Sevransky, MD, MHS

Principal Investigator

Emory University

Eligibility Criteria

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.

Inclusion Criteria

Lowest EMS systolic blood pressure <110 mmHg
Highest EMS pulse rate >90 beats per minute
EMS transport to a participating study ED/hospital
See 2 more

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)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Phase

Study sites participate in the standard of care phase to collect baseline data

6 to 18 months

Intervention Phase

Implementation of the PRESS protocol with sepsis screening and early warning protocol

6 to 18 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

up to 20 days

Treatment Details

Interventions

  • PRESS Intervention
Trial Overview 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.
Participant Groups
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials
1,735
Recruited
2,605,000+

Centers for Disease Control and Prevention

Collaborator

Trials
902
Recruited
25,020,000+

Findings from Research

The implementation of the PRESS protocol significantly improved sepsis recognition by EMS providers, increasing identification rates from 12% to 59% after training, based on a study involving 276 patient encounters.
Patients identified as septic by EMS received antibiotics 24 minutes faster than those not identified, highlighting the protocol's potential to enhance timely treatment in emergency situations.
Implementation of an EMS protocol to improve prehospital sepsis recognition.Polito, CC., Bloom, I., Dunn, C., et al.[2022]
The implementation of a sepsis protocol in a Level III ICU resulted in improved delivery of care, including faster initiation of appropriate antibiotics and increased use of vasopressors and nutritional support among 110 patients studied.
Despite these improvements in care processes, the protocol did not lead to a reduction in ICU or hospital mortality rates for patients with severe sepsis or septic shock.
Implementation and outcomes of a severe sepsis protocol in an Australian tertiary hospital.Orford, NR., Faulkner, C., Flintoff, W., et al.[2019]
A prehospital sepsis screening protocol using SIRS criteria and low ETCO2 levels significantly improved the diagnosis rates of sepsis (78% vs 43%) and severe sepsis (47% vs 7%) among patients with suspected infections, based on a study of 330 sepsis alerts.
Low ETCO2 levels were identified as the strongest predictor of sepsis and severe sepsis, with the protocol demonstrating a high sensitivity of 90% for detecting severe sepsis, which could help reduce the time to treatment for affected patients.
A prehospital screening tool utilizing end-tidal carbon dioxide predicts sepsis and severe sepsis.Hunter, CL., Silvestri, S., Ralls, G., et al.[2022]

References

Implementation of an EMS protocol to improve prehospital sepsis recognition. [2022]
Implementation and outcomes of a severe sepsis protocol in an Australian tertiary hospital. [2019]
A prehospital screening tool utilizing end-tidal carbon dioxide predicts sepsis and severe sepsis. [2022]
The impact of a sepsis performance improvement program in the emergency department: a before-after intervention study. [2023]
Managed clinical protocol: impact of implementation on sepsis treatment quality indicators. [2022]
Multi-incident analysis of reviews of serious adverse clinical events in children with serious bacterial infection and/or sepsis in Queensland, Australia between 2012 and 2017. [2022]
The effects of implementation of the Surviving Sepsis Campaign in the Netherlands. [2022]
Frequency and Characterization of Tracheal Intubation Adverse Events in Pediatric Sepsis. [2019]
Sepsis in Poland: why do we die? [2023]
10.United Statespubmed.ncbi.nlm.nih.gov
Prehospital Sepsis Project (PSP): knowledge and attitudes of United States advanced out-of-hospital care providers. [2013]
Computerised sepsis protocol management. Description of an early warning system. [2021]
Prehospital management and identification of sepsis by emergency medical services: a systematic review. [2018]
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