Impact of the Introduction of a Performance Improvement Program on the Initial Management of Sepsis and Septic Shock in Adults in the Emergency Department: a Before-and-after Study (IPA-SOS)
- Conditions
- Critical IllnessSepsisSeptic ShockEmergency MedicineSurviving Sepsis CampaignSepsis Performance Improvement ProgramSepsis Team
- Registration Number
- NCT06657625
- Lead Sponsor
- University Hospital, Brest
- Brief Summary
The goal of this observational study is to evaluate if a performance improvement program can improve the initial management of sepsis and septic shock in adults at Brest University Hospital. The study will include adult patients with positive blood cultures and a positive SOFA (Sequential Organ Failure Essessment) score, or with blood cultures collected, a positive SOFA score, and sepsis/septic shock confirmed by the sepsis team at Brest University Hospital.
The main questions it aims to answer are:
* Does the implementation of a performance improvement program increase adherence to the 2021 Surviving Sepsis Campaign (SSC) guidelines?
* Does the program improve patient outcomes, such as 90-day mortality, progression to septic shock, and length of stay in the ICU and hospital?
Researchers will compare patients from two periods : pre-implementation (January 1, 2017 to December 31, 2017) and post-implementation (May 1, 2022 to April 30, 2024), to see if the performance improvement program leads to better compliance with SSC guidelines and improved patient outcomes.
Participants will:
* Have their clinical data (such as blood cultures, SOFA scores, and treatment times) collected and analyzed.
* Be monitored for time to antibiotic therapy, initial fluid resuscitation, and other key treatment interventions following the recognition of sepsis or septic shock.
- Detailed Description
Sepsis and septic shock are conditions with a significant public health impact, yet the incidence of sepsis continues to rise. To improve the management of these conditions, experts recommend implementing performance improvement programs. These recommendations were applied at Brest University Hospital in 2018, including the creation of a "sepsis team" responsible for prevention, education, and providing guidance and advice on sepsis and septic shock. The team consists of infectious disease specialists, emergency physicians, and critical care doctors.
Due to the heterogeneity of such programs worldwide, it is important to assess the effectiveness of the performance improvement program at Brest University Hospital by evaluating adherence to the 2021 Surviving Sepsis Campaign (SSC) guidelines before and after its implementation.
The study will include adult patients with positive blood cultures and a positive SOFA score, or with blood cultures collected, a positive SOFA score, and sepsis/septic shock confirmed by the sepsis team at Brest University Hospital. Two periods : from 01/01/2017 to 31/12/2017 and from 01/05/2022 to 30/04/2024.
The pre- and post-implementation groups will be compared, with the primary outcome being compliance with the 2021 SSC recommendations (antibiotic therapy, hemodynamic management, respiratory support, corticosteroid therapy). Secondary outcomes include time from admission to first physician contact, time from first contact to initiation of antibiotic therapy, time from first contact to first fluid resuscitation, the proportion of sepsis patients progressing to septic shock in the emergency department, length of ICU and hospital stay, 90-day mortality, duration of mechanical ventilation, and changes in SOFA score (at 24 hours, Day 2, and Day 7).
The role of the Initial Orientation Nurse (ION) is integrated into the evaluation criteria. Using a triage grid, sometimes in collaboration with the senior emergency physician or resuscitation physician, the ION determines the optimal time frame for care and the most appropriate treatment pathway. The ION plays a key role in the early recognition of sepsis/septic shock.
The investigators will consider the time from patient evaluation by the ION to assess the speed of activation of the appropriate care pathway and the promptness of sepsis/septic shock management after recognition.
The objective of this study is to evaluate the impact of implementing a performance improvement program on the initial management of sepsis and septic shock in adults in the emergency medicine department of Brest University Hospital, guided by the 2021 Surviving Sepsis Campaign (SSC) guidelines.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 600
- Major
- Patients with positive blood cultures and a positive SOFA score
- Patients with blood cultures collected, a positive SOFA score, and sepsis/septic shock confirmed by the sepsis team at Brest University Hospital.
- Patients enrolled in a social security scheme
- Patients under judicial protection (guardianship, curatorship, etc.)
- Refusal to participate
- Pregnant patients
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Delay from Initial Orientation Nurse (ION) to initiation of antibiotic therapy Up to 6 hours Delay from Initial Orientation Nurse (ION) to initiation of antibiotic therapy in minutes.
From ION assessment to the first antibiotic administration in the emergency departement.
- Secondary Outcome Measures
Name Time Method Delay from Initial Orientation Nurse (ION) to initial fluid resuscitation Up to 6 hours Delay from Initial Orientation Nurse (ION) to initial fluid resuscitation in minutes.
From ION assessment to the first fluid administration in the emergency departement.Quality of fluid resuscitation Up to 3 hours Quality of fluid resuscitation is defined as a minimum of 30 mL/kg within 3 hours using crystalloid solutions, with a target mean arterial pressure (MAP) of 65 mmHg.
From ION assessment, to 3hours in the emergency departement.Quality of oxygen therapy Up to 6 hours Quality of oxygen therapy is defined as maintaining an SpO2 target of 94-96%, or 88-92% if the patient has chronic respiratory failure.
At the ION, at 3 hours, and at 6 hours in the emergency department.Quality of selected antibiotic therapy Up to 6hours The investigators use modified Gyssen score to evaluate the quality of antibiotic therapy.
It's a qualitative score; the response is whether the antibiotic is adapted or not.
At the time of the administration of the first dose of antibiotic in the emergency departement.Proportion of sepsis patients progressing to septic shock in the emergency department Up to 6 hours Progression of sepsis to septic shock is defined by the necessity for the administration of vasopressors to achieve a mean arterial pressure (MAP) of 65 mmHg after 3 hours in the emergency department.
Duration of hospitalization in the ICU and hospital, and length of stay in the emergency department Through study completion, an average of 6 months Duration of hospitalization in the ICU and hospital in days; and length of stay in the emergency department in hours.
Duration of mechanical ventilation Through study completion, an average of 6 months Duration of mechanical ventilation is defined as the cumulative time of intubation (IOT) with invasive ventilation (IV) in days during hospitalization in the ICU following initial care in emergency departement.
Changes in the SOFA score Up to day 7 Calculation of the SOFA score. At ION in emergency departement, 24 hours, Day 2, and Day 7. The SOFA score is out of 24, and it is considered positive from 2 points onwards. The higher the score, the greater the severity.
28-day mortality Up to days 28 Death within 28 days of administrative admission.
90-day mortality Up to days 90 Death within 90 days of administrative admission.
Trial Locations
- Locations (1)
Chu Brest
đŸ‡«đŸ‡·Brest, France