Delta qSOFA for Risk Stratification in Emergency Infected Patients
NCT ID: NCT02926664
Last Updated: 2017-10-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
512 participants
OBSERVATIONAL
2016-10-31
2017-05-01
Brief Summary
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Interventions
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measurement of qSOFA
qSOFA will be measured at H0, H1 and H3
Eligibility Criteria
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Inclusion Criteria
* at least two of the following criteria : respiratory rate \<= 22, systolic blood pressure \<= 100 mmHg and altered mental status
Exclusion Criteria
* patient who refuse to participate
18 Years
ALL
No
Sponsors
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Societe Française de Medecine d'urgence
OTHER
Responsible Party
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Yonathan Freund
Associate professor
Principal Investigators
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Yonathan Freund
Role: PRINCIPAL_INVESTIGATOR
Emergency Department - hopital pitie salpetriere, Paris, France
Locations
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Cliniques St Luc
Brussels, , Belgium
CHU Nimes
Nîmes, , 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
Countries
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Other Identifiers
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DeltaSCREEN
Identifier Type: -
Identifier Source: org_study_id