Prehospital Sepsis Protocol for Sepsis
(IMPRESS Trial)
Recruiting in Palo Alto (17 mi)
+2 other locations
Overseen byCarmen C Polito, MD, MSc
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Emory University
Disqualifiers: Trauma, Cardiac arrest, Pregnancy, others
No Placebo Group
Trial Summary
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).
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.
12345Is 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.
16789How 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.
13101112Eligibility 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
+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)
Trial 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
Participant Groups
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.
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
Research Locations NearbySelect from list below to view details:
University of IowaIowa City, IA
Washington UniversitySaint Louis, MO
Emory University HospitalAtlanta, GA
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Who Is Running the Clinical Trial?
Emory UniversityLead Sponsor
Centers for Disease Control and PreventionCollaborator
References
Implementation of an EMS protocol to improve prehospital sepsis recognition. [2022]Optimal sepsis outcomes are achieved when sepsis is recognized early. Recognizing sepsis in the prehospital, EMS setting can be challenging and unreliable. The purpose of this study is to evaluate whether implementation of an EMS sepsis screening and prehospital alert protocol called PRESS (PREhospital SepsiS) is associated with improved sepsis recognition by EMS providers.
Implementation and outcomes of a severe sepsis protocol in an Australian tertiary hospital. [2019]To evaluate the effect of implementation of a sepsis protocol.
A prehospital screening tool utilizing end-tidal carbon dioxide predicts sepsis and severe sepsis. [2022]To determine the utility of a prehospital sepsis screening protocol utilizing systemic inflammatory response syndrome (SIRS) criteria and end-tidal carbon dioxide (ETCO2).
The impact of a sepsis performance improvement program in the emergency department: a before-after intervention study. [2023]The latest Surviving Sepsis Campaign guidelines advocate that all hospitals use sepsis performance improvement programs. However, there is a limited evidence about how to structure such programs and what their potential impact is on sepsis management and outcomes in the emergency department (ED). In this study, we evaluated the implementation of a sepsis performance improvement program in the ED including a dedicated sepsis response team and analyzed the management and outcomes of sepsis patients before and after.
Managed clinical protocol: impact of implementation on sepsis treatment quality indicators. [2022]to assess the impact of the implementation of a managed sepsis protocol on quality indicators of treatment for septic patients in an emergency department of a university hospital.
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]To report on findings from a multi-incident analysis of reviews of serious paediatric adverse clinical events related to serious bacterial infection and/or sepsis (hereafter referred to as sepsis for brevity) in Queensland, Australia, between 2012 and 2017.
The effects of implementation of the Surviving Sepsis Campaign in the Netherlands. [2022]To reduce unintentional and avoidable adverse events in patients in hospitals in the Netherlands, a patient safety agency (VMS) programme was launched in 2008. Among the VMS topics, the programme 'optimal therapy in severe sepsis', according to the international Surviving Sepsis Campaign (SSC), aims to improve early diagnosis and treatment of sepsis to reduce sepsis mortality by 15% before the end of 2012. We analysed compliance data submitted to the international SSC database from the Netherlands and compared these data with published international SS C results. Data of 863 patients, representing 6% of the international data (n=14,209), were used for analysis. In the Netherlands, the resuscitation bundle compliance improved significantly from 7% at baseline to 27% after two years (p=0.002). Internationally, the resuscitation bundle compliance increased significantly from 11 to 31% (p.
Frequency and Characterization of Tracheal Intubation Adverse Events in Pediatric Sepsis. [2019]Intubation in critically ill pediatric patients is associated with approximately 20% rate of adverse events, but rates in the high-risk condition of sepsis are unknown. Our objectives were to describe the frequency and characteristics of tracheal intubation adverse events in pediatric sepsis.
Sepsis in Poland: why do we die? [2023]To investigate the adverse events and potential risk factors in patients who develop sepsis.
Prehospital Sepsis Project (PSP): knowledge and attitudes of United States advanced out-of-hospital care providers. [2013]Severe sepsis and septic shock are common and often fatal medical problems. The Prehospital Sepsis Project is a multifaceted study that aims to improve the out-of-hospital care of patients with sepsis by means of education and enhancement of skills. The objective of this Project was to assess the knowledge and attitudes in the principles of diagnosis and management of sepsis in a cohort of United States out-of-hospital care providers.
Computerised sepsis protocol management. Description of an early warning system. [2021]New strategies need to be developed for the early recognition and rapid response for the management of sepsis. To achieve this purpose, the Multidisciplinary Sepsis Team (MST) developed the Computerised Sepsis Protocol Management (PIMIS). The aim of this study was to evaluate the convenience of using PIMIS, as well as the activity of the MST.
Prehospital management and identification of sepsis by emergency medical services: a systematic review. [2018]To identify studies describing the accuracy of prehospital sepsis identification and to summarise results of studies of prehospital management of patients with sepsis, severe sepsis or septic shock.