Delta qSOFA for Risk Stratification in Emergency Infected Patients

Sepsis Clinical Trial

— DELTASCREEN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02926664
• Other study ID #: DeltaSCREEN
• Status: Completed
• Phase: N/A
• First received: October 5, 2016
• Last updated: October 21, 2017
• Start date: October 2016
• Est. completion date: May 1, 2017

Study information

• Verified date: October 2017
• Source: Societe Française de Medecine d'urgence
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 512
• Est. completion date: May 1, 2017
• Est. primary completion date: May 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Emergencies
• Sepsis

Intervention

Other:
• measurement of qSOFA
qSOFA will be measured at H0, H1 and H3

Locations

Country	Name	City	State
Belgium	Cliniques St Luc	Bruxelles
France	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
Spain	Hospital Clinic	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Societe Française de Medecine d'urgence

Countries where clinical trial is conducted

Belgium,  France,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	In-hospital mortality		60 days
Secondary	ICU admission more than 72 hours		60 days
Secondary	ICU admission		60 days