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Enrolling by invitationOBSERVATIONAL

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)

This study, called IPA-SOS, is checking if a special programme at Brest University Hospital helps doctors and nurses better manage serious blood infections like sepsis and septic shock in adults. Sepsis is when your body has an extreme response to an infection. Septic shock is an even more severe stage. Researchers are comparing patient care and outcomes before the programme started (2017) and after it was put in place (2022-2024). They want to know if the hospital staff follow the latest treatment guidelines more closely and if patients get better, for example, by spending less time in intensive care and generally recovering more successfully. This is an observational study, meaning no new treatments are given; existing patient data is simply reviewed.

At a glance

Status
Enrolling by invitation
Sponsor
University Hospital, Brest
Enrolment target
600
Start
01 Aug 2024
Estimated completion
31 Jul 2026

What is this study about?

Imagine your body's immune system going into overdrive because of an infection – that's sepsis, and it can be very serious. If it gets even worse, it's called septic shock. Both conditions need quick and appropriate treatment. Doctors and nurses have special guidelines to help them treat patients effectively, aiming to give the best care possible.

At Brest University Hospital, they introduced a special 'Performance Improvement Program' and a 'sepsis team' in 2018. This team includes infection specialists and emergency doctors, focusing on teaching, preventing, and advising on sepsis care. This study is like taking a snapshot of how things were before the programme and comparing it to how things are now. Researchers want to see if this programme has actually made a difference in how staff treat sepsis and septic shock, and, most importantly, if it leads to better results for patients.

They're looking at things like how quickly antibiotics are given, how long patients stay in the hospital or intensive care, and how many patients go on to develop septic shock or sadly, don't survive. By comparing these before and after the programme was introduced, the study aims to understand if this kind of organised effort really helps improve care for people with these serious conditions. It's about finding the best ways to help people get better.

Key takeaways

  • This study evaluates how a hospital programme impacts sepsis care.
  • It uses existing patient medical records from before and after the programme was introduced.
  • The aim is to see if guidelines are followed better and if patient outcomes improve.
  • Sepsis and septic shock are serious infections requiring quick treatment.
  • There are no direct risks or new treatments involved for patients whose data is used.

Who may be eligible?

This study is looking at information from adults who were treated at Brest University Hospital for sepsis or septic shock.

You might be included if you were an adult patient and had specific blood test results (positive blood cultures) along with a certain score (called a SOFA score) that indicates organ problems. Or, you might have been included if you had blood tests taken, a positive SOFA score, and the hospital's 'sepsis team' confirmed you had sepsis or septic shock.

However, you couldn't be included if you were under legal guardianship (like a court-appointed protector), if you didn't want your information used for the study, or if you were pregnant.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Were you an adult patient (18 years or older)?
  2. Did you receive care at Brest University Hospital?
  3. Were you treated for sepsis or septic shock?
  4. Were specific blood tests and scores (like SOFA) recorded?
  5. Were you not pregnant at the time of treatment?
  6. Were you not under certain legal protections (like guardianship)?
Answer every question to see your result.

What does participation involve?

If your past medical records are included in this study, you won't need to do anything extra. This is an 'observational study,' which means researchers are simply looking back at existing health information from patients. They are not asking anyone to take new medicines, have extra appointments, or change their regular care.

The researchers will be collecting and analysing information that's already in your medical notes, such as results from blood tests (like blood cultures), your SOFA scores (which show how well your organs are working), and details about the treatments you received, like when antibiotics were given and how much fluid you received. This helps them understand how quickly and effectively sepsis was managed during your hospital stay.

Your participation is passive, meaning you don't actively 'take part' in the traditional sense. The study simply reviews anonymous medical data collected during past hospital visits. There are no study visits, no special assessments, and no follow-up required from you. The study simply observes and analyses care that has already happened.

Potential risks and benefits

Because this study only involves looking at existing, de-identified medical records, there are no direct risks or physical benefits to you. Your identity will be kept private, and the information used will not be linked back to you personally. The potential benefit of this study is that it might help hospitals improve how they care for patients with sepsis and septic shock in the future, leading to better outcomes for everyone. While you are not directly involved in giving consent for this type of research on anonymised data, you always have the right to ask your care team about studies looking at past patient data and how your privacy is protected.

Locations (1)

  • Chu Brest
    Verified postcode
    Brest, France

Common questions

What is sepsis?

Sepsis is a very serious condition where your body's response to an infection damages its own tissues and organs. It needs urgent medical attention.

What is septic shock?

Septic shock is the most severe form of sepsis, where your blood pressure drops dangerously low, and your organs might not get enough blood. It's a life-threatening emergency.

What is the 'sepsis team'?

This is a special group of doctors at the hospital, including infection specialists and emergency doctors, who work together to improve care for sepsis patients.

Will I receive any new treatments in this study?

No, this study only looks at past medical records. No new treatments are given, and your care would not be changed by this study.

How will my privacy be protected?

The study uses your health information in a way that keeps your identity private. No one will be able to link the study information back to you personally.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Impact of the Introduction of a Performance Improvement Prog…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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