Delta qSOFA for Risk Stratification in Emergency Infected Patients

Completed

• Conditions: Sepsis

• Registration Number: NCT02926664
• Lead Sponsor: Societe Française de Medecine d'urgence

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.

Study Timeline

• Study Start: 2016-10
• Study First Submitted: 2016-10-05
• Study First Submitted QC: 2016-10-05
• Study First Posted: 2016-10-06
• Primary Completion: 2017-05-01
• Study Completion: 2017-05-01
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-21
• Last Update Posted: 2017-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 512

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
In-hospital mortality	60 days

Secondary Outcome Measures

Name	Time	Method
ICU admission more than 72 hours	60 days
ICU admission	60 days

Trial Locations

Locations (10)

Cliniques St Luc; 🇧🇪 Bruxelles, Belgium

CHU Nimes; 🇫🇷 Nimes, France

Cochin; 🇫🇷 Paris, France

Hopital Europeen Georges Pompidou; 🇫🇷 Paris, France

Hopital Pitié-Salpêtrière; 🇫🇷 Paris, France

Hopital Tenon; 🇫🇷 Paris, France

Lariboisière; 🇫🇷 Paris, France

Saint Antoine; 🇫🇷 Paris, France

CHU Strasbourg; 🇫🇷 Strasbourg, France

Hospital Clinic; 🇪🇸 Barcelona, Spain