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Delta qSOFA for Risk Stratification in Emergency Infected Patients (DELTASCREEN)

S

Societe Française de Medecine d'urgence

Status

Completed

Conditions

Sepsis

Treatments

Other: measurement of qSOFA

Study type

Observational

Funder types

Other

Identifiers

NCT02926664
DeltaSCREEN

Details and patient eligibility

About

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.

Full 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.

Enrollment

512 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

10

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Data sourced from clinicaltrials.gov

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