Sepsis
Conditions
Brief summary
The study will investigate the prognostic value of qSOFA (quick Sequential Organ Failure Assessment) kinetics between H0 and H1, and between H0 and H3 in patients with suspicion of Sepsis, i.e. an initial qSOFA of at least of 2.
Detailed description
qSOFA has been reported as a good tool for risk stratification in the ED for patients with infection. However, it is not clear whether qSOFA remains stable during the ED stay, nor whether its kinetics can have prognostic added value. Patients with a qSOFA of at least 2 in the ED, and suspicion of infection will be included. After treatment is initiated and fluids challenge performed, we will collect qSOFA value at 1 hour and 3 hours. Our hypothesis is that a decrease in qSOFA between H0 and H3 is associated with better outcome. We assume that 50% of patients will have a deltaqSOFA \>0, with an overall mortality of 23% (according to previous cohort). Under the hypothesis of difference of at least 15% in mortality between the two groups (DeltaqSOFA \> 0 and Delta qSOFA\<=0), with a power of 90% and an alpha of 0.05, we need to recruit 322 patients.
Interventions
OTHERmeasurement of qSOFA
qSOFA will be measured at H0, H1 and H3
Sponsors
Societe Française de Medecine d'urgence
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* suspicion of infection by the emergency physicians * at least two of the following criteria : respiratory rate \<= 22, systolic blood pressure \<= 100 mmHg and altered mental status
Exclusion criteria
* Infection ruled out by the expert after chart review * patient who refuse to participate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| In-hospital mortality | 60 days |
Secondary
| Measure | Time frame |
|---|---|
| ICU admission more than 72 hours | 60 days |
| ICU admission | 60 days |
Countries
Belgium, France, Spain
Outcome results
None listed