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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:
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pre-implementation cohort | Patients from January 1, 2017, to December 31, 2017, before the implementation of the performance improvement program. | ||
| Post-implementation cohort | Patients from May 1, 2022, to April 30, 2024, after the implementation of the performance improvement program. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sepsis Performance Improvement Program | Other | Training/awareness for medical and paramedical staff; creation of informational posters; development of an institutional pathway in the emergency department; creation of a protocol ; establishment of a sepsis team with a dedicated contact number. |
| Measure | Description | Time Frame |
|---|---|---|
| Delay from Initial Orientation Nurse (ION) to initiation of antibiotic therapy | 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. | Up to 6 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of selected antibiotic therapy | 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. | Up to 6hours |
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Inclusion Criteria:
Exclusion Criteria:
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All patients with blood cultures collected and a SOFA score ≥ 2 presenting to the emergency department of Brest University Hospital, between January 1, 2017, to December 31, 2017 and May 1, 2022, to April 30, 2024.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chu Brest | Brest | 29609 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Rezig S, Branthome S, Basset A, Helies R, Fiore C, Bailly P, et al. Une "Sepsis Team" est elle indispensable dans chaque hopital ? Médecine Mal Infect. 1 juin 2019;49:S55-6. | ||
| 31954465 | Background | Rudd KE, Johnson SC, Agesa KM, Shackelford KA, Tsoi D, Kievlan DR, Colombara DV, Ikuta KS, Kissoon N, Finfer S, Fleischmann-Struzek C, Machado FR, Reinhart KK, Rowan K, Seymour CW, Watson RS, West TE, Marinho F, Hay SI, Lozano R, Lopez AD, Angus DC, Murray CJL, Naghavi M. Global, regional, and national sepsis incidence and mortality, 1990-2017: analysis for the Global Burden of Disease Study. Lancet. 2020 Jan 18;395(10219):200-211. doi: 10.1016/S0140-6736(19)32989-7. | |
| 25946168 |
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All collected data that underlie results in a publication
Data will be available beginning three years and ending fifteen years following the final study report completion
Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement
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|
|
| Delay from Initial Orientation Nurse (ION) to initial fluid resuscitation |
Delay from Initial Orientation Nurse (ION) to initial fluid resuscitation in minutes. From ION assessment to the first fluid administration in the emergency departement. |
| Up to 6 hours |
| Quality of fluid resuscitation | 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. | Up to 3 hours |
| Quality of oxygen therapy | 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. | Up to 6 hours |
| Proportion of sepsis patients progressing to septic shock in the emergency department | 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. | Up to 6 hours |
| Duration of hospitalization in the ICU and hospital, and length of stay in the emergency department | Duration of hospitalization in the ICU and hospital in days; and length of stay in the emergency department in hours. | Through study completion, an average of 6 months |
| Duration of mechanical ventilation | 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. | Through study completion, an average of 6 months |
| Changes in the SOFA score | 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. | Up to day 7 |
| 28-day mortality | Death within 28 days of administrative admission. | Up to days 28 |
| 90-day mortality | Death within 90 days of administrative admission. | Up to days 90 |
| Background |
| Damiani E, Donati A, Serafini G, Rinaldi L, Adrario E, Pelaia P, Busani S, Girardis M. Effect of performance improvement programs on compliance with sepsis bundles and mortality: a systematic review and meta-analysis of observational studies. PLoS One. 2015 May 6;10(5):e0125827. doi: 10.1371/journal.pone.0125827. eCollection 2015. |
| 34605781 | Background | Evans L, Rhodes A, Alhazzani W, Antonelli M, Coopersmith CM, French C, Machado FR, Mcintyre L, Ostermann M, Prescott HC, Schorr C, Simpson S, Wiersinga WJ, Alshamsi F, Angus DC, Arabi Y, Azevedo L, Beale R, Beilman G, Belley-Cote E, Burry L, Cecconi M, Centofanti J, Coz Yataco A, De Waele J, Dellinger RP, Doi K, Du B, Estenssoro E, Ferrer R, Gomersall C, Hodgson C, Hylander Moller M, Iwashyna T, Jacob S, Kleinpell R, Klompas M, Koh Y, Kumar A, Kwizera A, Lobo S, Masur H, McGloughlin S, Mehta S, Mehta Y, Mer M, Nunnally M, Oczkowski S, Osborn T, Papathanassoglou E, Perner A, Puskarich M, Roberts J, Schweickert W, Seckel M, Sevransky J, Sprung CL, Welte T, Zimmerman J, Levy M. Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock 2021. Crit Care Med. 2021 Nov 1;49(11):e1063-e1143. doi: 10.1097/CCM.0000000000005337. No abstract available. |
| 33492864 | Background | Chiu C, Legrand M. Epidemiology of sepsis and septic shock. Curr Opin Anaesthesiol. 2021 Apr 1;34(2):71-76. doi: 10.1097/ACO.0000000000000958. |
| 36394818 | Background | Schinkel M, Holleman F, Vleghels R, Brugman K, Ridderikhof ML, Dzelili M, Nanayakkara PWB, Wiersinga WJ. The impact of a sepsis performance improvement program in the emergency department: a before-after intervention study. Infection. 2023 Aug;51(4):945-954. doi: 10.1007/s15010-022-01957-x. Epub 2022 Nov 17. |
| ID | Term |
|---|---|
| D018805 | Sepsis |
| D012772 | Shock, Septic |
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |
| D020969 | Disease Attributes |
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