Status:
COMPLETED
Effect of the 1-hour Sepsis Bundle on In-hospital Mortality in Patients With Sepsis in the Emergency Department
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Sepsis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Reducing the mortality and morbidity of sepsis is a worldwide priority for almost 20 years. Since an observational study in the NY state, which reported in-hospital mortality increased, associated wit...
Detailed Description
In Europe, one third of patients with sepsis and septic shock are admitted through the emergency department (ED), with an overall in-hospital mortality of 20%, and 90 days mortality of 25%. Reducing t...
Eligibility Criteria
Inclusion
- ED adult patients, with suspected infection
- Free given Oral consent given by the patient or by the trustworthy person / family member / close relative or inclusion in case of emergency.
- AND at least one of the following:
- Serum lactate \> 2.0 mmol/l
- Systolic blood pressure \< 90 mmHg
- Suspicion of sepsis as defined by the SEPSIS-3 International consensus: life threatening organ dysfunction identified by a SOFA score of 2 at least or a quick SOFA score of 2 at least (altered consciousness, systolic blood pressure \< 100 mmHg, respiratory rate \> 22)
- For French sites, free given Oral consent given by the patient or by the trustworthy person / family member / close relative or inclusion in case of emergency. According to the Biomedical Research Law 14/2007 in Spain, the emergency consent is not apply. The written patient consent is mandatory.
Exclusion
- Patient living in assisted-living home or nursing home or palliative center
- Patient under legal protection measure (tutorship or curatorship) and patient deprived of freedom
- Anticipated life expectancy \< 3 months or "do not resuscitate" order
- Known acute heart failure
- No social security
- Pregnancy and breastfeeding
- Prisoners
- Participation in another interventional trial (RIPH 1 et 2)
- Patients that presented inclusion criteria more than 3 hours before inclusion
- Patient in whom antibiotics or fluid resuscitation has been started before inclusion
Key Trial Info
Start Date :
June 13 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 13 2023
Estimated Enrollment :
873 Patients enrolled
Trial Details
Trial ID
NCT05273034
Start Date
June 13 2022
End Date
October 13 2023
Last Update
February 26 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Emergency department Hospital Pitié-Salpêtrière
Paris, France, 75013