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

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

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.

Study Overview

• Status: Completed
• Conditions: Sepsis
• Intervention / Treatment: Other: measurement of qSOFA

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.

• Study Type: Observational
• Enrollment (Actual): 512

Contacts and Locations

Study Locations

• Belgium
  • Bruxelles, Belgium
    • Cliniques St Luc
• France
  • Nimes, France
    • CHU Nimes
  • Paris, France
    • Hôpital Pitié-Salpêtrière
  • Paris, France
    • Hôpital Européen Georges Pompidou
  • Paris, France
    • Hopital Tenon
  • Paris, France
    • COCHIN
  • Paris, France
    • Lariboisière
  • Paris, France
    • Saint Antoine
  • Strasbourg, France
    • CHU Strasbourg
• Spain
  • Barcelona, Spain
    • Hospital Clínic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult patients in the ED who presents with suspicion of infection AND a qSOFA of at least 2.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
In-hospital mortality	60 days

Secondary Outcome Measures

Outcome Measure	Time Frame
ICU admission more than 72 hours	60 days
ICU admission	60 days

Collaborators and Investigators

• Sponsor: Societe Française de Medecine d'urgence
• Investigators: Principal Investigator: Yonathan Freund, Emergency Department - hopital pitie salpetriere, Paris, France

Study record dates

Study Major Dates

• Study Start: October 1, 2016
• Primary Completion (Actual): May 1, 2017
• Study Completion (Actual): May 1, 2017

Study Registration Dates

• First Submitted: October 5, 2016
• First Submitted That Met QC Criteria: October 5, 2016
• First Posted (Estimate): October 6, 2016

Study Record Updates

• Last Update Posted (Actual): October 24, 2017
• Last Update Submitted That Met QC Criteria: October 21, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies
• Other Study ID Numbers: DeltaSCREEN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: data will be available upon request to the principal investigator