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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)

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

Status
Enrolling by invitation
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06657625
Acronym
IPA-SOS
Enrollment
600
Registered
2024-10-24
Start date
2024-08-01
Completion date
2026-07-31
Last updated
2024-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Illness, Emergency Medicine, Sepsis, Sepsis Performance Improvement Program, Sepsis Team, Septic Shock, Surviving Sepsis Campaign

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.

Interventions

OTHERSepsis Performance Improvement Program

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.

Sponsors

University Hospital, Brest
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* Patients under judicial protection (guardianship, curatorship, etc.) * Refusal to participate * Pregnant patients

Design outcomes

Primary

MeasureTime frameDescription
Delay from Initial Orientation Nurse (ION) to initiation of antibiotic therapyUp to 6 hoursDelay 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

MeasureTime frameDescription
Delay from Initial Orientation Nurse (ION) to initial fluid resuscitationUp to 6 hoursDelay 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 resuscitationUp to 3 hoursQuality 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 therapyUp to 6 hoursQuality 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.
Proportion of sepsis patients progressing to septic shock in the emergency departmentUp to 6 hoursProgression 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.
Quality of selected antibiotic therapyUp to 6hoursThe 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.
Duration of mechanical ventilationThrough study completion, an average of 6 monthsDuration 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 scoreUp to day 7Calculation 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 mortalityUp to days 28Death within 28 days of administrative admission.
90-day mortalityUp to days 90Death within 90 days of administrative admission.
Duration of hospitalization in the ICU and hospital, and length of stay in the emergency departmentThrough study completion, an average of 6 monthsDuration of hospitalization in the ICU and hospital in days; and length of stay in the emergency department in hours.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026