Prehospital Sepsis Protocol for Sepsis

(IMPRESS Trial)

No longer recruiting at 3 trial locations

Overseen By Jonathan E Sevransky, MD, MHS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Emory University

Disqualifiers: Trauma, Cardiac arrest, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method for emergency medical teams to quickly identify and respond to sepsis, a serious infection that can lead to organ failure, as soon as a patient arrives at the hospital. The trial aims to determine if a special protocol, called the PRESS Intervention, can expedite the initiation of crucial treatments. Participants are divided into two groups: one will use this new method, while the other will follow the usual care. Suitable candidates exhibit symptoms such as a high pulse or difficulty breathing and are being taken to a participating hospital. As an unphased trial, this study offers participants the chance to contribute to innovative approaches in emergency care.

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 prior data suggests that this protocol is safe?

Research shows that the PRESS Intervention aims to identify and treat sepsis early, before patients reach the hospital. Studies have found that early detection and treatment of sepsis can improve patient outcomes. The intervention trains emergency medical services (EMS) to use early warning scores, tools designed to identify patients at high risk for sepsis.

Specific data on negative effects related to the PRESS Intervention is not available, but it focuses on improving the timing and delivery of care rather than introducing new drugs or treatments. This approach enhances current care practices, which generally makes it well-tolerated. The adoption of this protocol by the State of South Carolina's EMS indicates confidence in its safety and effectiveness. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the PRESS Intervention for sepsis because it aims to optimize prehospital care, potentially improving outcomes before patients even reach the hospital. Unlike the standard approach, which typically begins intensive treatment upon hospital arrival, this intervention focuses on early recognition and management of sepsis symptoms by emergency medical services. By implementing this protocol in the field, the hope is to reduce delays in treatment, which can be crucial for improving survival rates and recovery in sepsis patients.

What evidence suggests that this protocol is effective for sepsis?

Research has shown that the PRESS Intervention, which participants in this trial may receive, helps emergency medical services (EMS) recognize sepsis earlier. One study found that a special EMS protocol improved the frequency of sepsis identification, enabling EMS teams to spot sepsis before patients reach the hospital. Early detection is crucial because it can lead to quicker treatment, potentially improving patient health. Another study found that starting treatment early, even before hospital arrival, might benefit patients in septic shock. Overall, these findings suggest that the PRESS Intervention could effectively recognize and manage sepsis early. ^{1 3 6 7 8}

Who Is on the Research Team?

Carmen C Polito, MD, MSc

Principal Investigator

Emory University

Jonathan E Sevransky, MD, MHS

Principal Investigator

Emory University

Are You a Good Fit for This Trial?

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

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: PRESS Intervention Experimental Treatment 1 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 Care Active Control 1 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.

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+

Published Research Related to This Trial

A patient safety program in the Netherlands aimed at improving the early diagnosis and treatment of severe sepsis led to a significant increase in compliance with the resuscitation bundle from 7% to 27% over two years, indicating improved patient care.

The Netherlands' compliance improvement was notable compared to international data, which showed an increase from 11% to 31%, suggesting that targeted programs can enhance adherence to sepsis treatment protocols and potentially reduce mortality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of implementation of the Surviving Sepsis Campaign in the Netherlands. Tromp, M., Tjan, DH., van Zanten, AR., et al.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A prehospital screening tool utilizing end-tidal carbon dioxide predicts sepsis and severe sepsis. Hunter, CL., Silvestri, S., Ralls, G., 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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation and outcomes of a severe sepsis protocol in an Australian tertiary hospital. Orford, NR., Faulkner, C., Flintoff, W., et al.[2019]

A study analyzing 55 sepsis cases in Poland found that the most common medical errors stemmed from a lack of knowledge regarding recognition, diagnosis, and treatment of sepsis, leading to adverse events.

Key risk factors for these adverse events included communication errors, insufficient medical staff, and a tendency to simplify serious symptoms, highlighting the need for improved training and management protocols for healthcare workers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sepsis in Poland: why do we die? Rorat, M., Jurek, T.[2023]

Emergency medical services (EMS) have variable success in identifying sepsis in prehospital settings, with sensitivity rates ranging from 0.43 to 0.86 depending on the criteria used, indicating a need for improved diagnostic strategies.

The most common treatment provided by EMS for sepsis is intravenous fluid resuscitation, but the overall quality of evidence regarding prehospital management is low, highlighting the necessity for further research to enhance both identification and treatment of sepsis in emergency situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prehospital management and identification of sepsis by emergency medical services: a systematic review. Lane, D., Ichelson, RI., Drennan, IR., et al.[2018]

The implementation of a managed sepsis protocol in an emergency department significantly improved the quality of treatment for septic patients, increasing the likelihood of receiving recommended care by 14 times.

The protocol not only reduced the average hospitalization period by 6 days but also led to a decrease in mortality rates, highlighting its efficacy in managing sepsis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Managed clinical protocol: impact of implementation on sepsis treatment quality indicators. Borguezam, CB., Sanches, CT., Albaneser, SPR., et al.[2022]

A survey of 226 advanced EMS providers revealed a concerning lack of knowledge about sepsis diagnosis and management, with only 9.8% answering all scenarios correctly, indicating a significant gap in education.

The study highlights the need for improved training and educational resources for EMS providers, as neither the level of training nor years of service correlated with correct responses, suggesting that current educational methods may be insufficient.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prehospital Sepsis Project (PSP): knowledge and attitudes of United States advanced out-of-hospital care providers. Báez, AA., Hanudel, P., Perez, MT., et al.[2013]

A multi-incident analysis of 28 serious adverse events related to paediatric sepsis in Queensland revealed a high mortality rate, particularly in children under 4 years old, highlighting the vulnerability of this age group.

Key contributing factors to these adverse events included difficulties in recognizing deteriorating patients, diagnostic delays, and communication issues within healthcare systems, suggesting areas for improvement to enhance early identification and treatment of sepsis in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Coulthard, MG., Osborne, JM., McCaffery, K., et al.[2022]

In a study of 118 critically ill pediatric patients with sepsis requiring intubation, 43% experienced adverse events, indicating a higher risk compared to other nonelective intubations.

The most common severe adverse event was hypotension, occurring in 17% of cases, while the first attempt success rate for intubation was only 57%, particularly lower among residents and general pediatricians.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Frequency and Characterization of Tracheal Intubation Adverse Events in Pediatric Sepsis. Schmidt, SK., Brou, L., Deakyne, SJ., et al.[2019]

The Computerised Sepsis Protocol Management (PIMIS) system was effectively utilized in 65.1% of the 1,581 consultations, indicating its convenience and usefulness in managing sepsis cases.

The Multidisciplinary Sepsis Team (MST) achieved a high acceptance rate of 78.1% for their antimicrobial prescription recommendations, demonstrating the team's impact on improving treatment strategies for sepsis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computerised sepsis protocol management. Description of an early warning system. de Dios, B., Borges, M., Smith, TD., et al.[2021]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of an EMS protocol to improve prehospital sepsis recognition. Polito, CC., Bloom, I., Dunn, C., et al.[2022]

The implementation of a sepsis performance improvement program in the emergency department led to significant improvements in process-related outcomes, such as a reduction in time to antibiotics (66 minutes post-intervention vs. 143 minutes pre-intervention) and an increase in lactate measurements (72.9% vs. 46.2%).

Despite these process improvements, the program did not significantly reduce patient-related outcomes like 28-day mortality, which remained similar between pre- and post-intervention phases (14.3% vs. 9.1%).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of a sepsis performance improvement program in the emergency department: a before-after intervention study. Schinkel, M., Holleman, F., Vleghels, R., et al.[2023]

Citations

1. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0735675722002650

Implementation of an EMS protocol to improve prehospital ... The sensitivity of the prehospital sepsis alert protocol was approximately 53%. This is in line with recently published literature showing a 59% rate of sepsis ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10873999/

The prehospital NEW score to assess septic shock in- ... A prehospital NEWS-2 ≥ 7 is associated with an increase in in-hospital, 30 and 90-day mortality of septic shock patients cared for by a MICU in ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05502107?cond=Sepsis&term=impress%20protocol&rank=1

Impact of a Prehospital Sepsis Protocol on Timely Antibiotic ... PRESS Intervention ... This dataset will include participant demographics, EMS physiologic data, as well as sepsis screening, classification, and outcomes data.

4. bmcemergmed.biomedcentral.com bmcemergmed.biomedcentral.com/articles/10.1186/s12873-024-01137-0

Sepsis management in pre-hospital care – the earlier, the ... On the other hand, in septic shock patients, early intervention may improve outcomes even in pre-hospital care. ... Impact of Prehospital Care on ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35500527/

Implementation of an EMS protocol to improve prehospital ... Implementation of an EMS sepsis screening and prehospital alert protocol was associated with an increase in sepsis recognition rates by EMS providers.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8810268/

Can Prehospital Data Improve Early Identification of Sepsis ... Early identification is necessary to reduce the negative impact of sepsis and to improve patient outcomes. ... prehospital data for improved patient outcomes.

7. emj.bmj.com emj.bmj.com/content/40/11/768

Prehospital early warning scores for adults with suspected ... Ambulance services can use prehospital early warning scores to identify people with a high risk of sepsis.5 Early warning scores use clinical observations to ...

8. emra.org emra.org/emresident/article/preshospital-sepsis-alerts-a-stemi-or-stroke-equivalent

Preshospital Sepsis Alerts: A Stemi or Stroke Equivalent? While outcome data is still forthcoming, the protocol has been so successful that it has been adopted by the State of South Carolina”™s EMS ...