NCT02926664

Delta qSOFA for Risk Stratification in Emergency Infected Patients

Prognostic Value of Quick Sequential Organ Failure Assessment Kinetics After Fluids Challenge in the Emergency Department

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 512 (actual)
• Sponsor: Societe Française de Medecine d'urgence · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sepsis

Interventions

Type	Name	Description
OTHER	measurement of qSOFA	qSOFA will be measured at H0, H1 and H3

Timeline

• Start date: 2016-10-01
• Primary completion: 2017-05-01
• Completion: 2017-05-01
• First posted: 2016-10-06
• Last updated: 2017-10-24

Locations

10 sites across 3 countries: Belgium, France, Spain