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SEPSIS 3 Critera for Risk Stratification in Emergency Patients (SCREEN)

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ClinicalTrials.gov Identifier: NCT02738164
Recruitment Status : Completed
First Posted : April 14, 2016
Last Update Posted : July 19, 2016
Sponsor:
Information provided by (Responsible Party):
Societe Française de Medecine d'urgence

Tracking Information
First Submitted Date April 2, 2016
First Posted Date April 14, 2016
Last Update Posted Date July 19, 2016
Study Start Date May 2016
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 8, 2016)
In hospital mortality [ Time Frame: 30 days ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: April 8, 2016)
  • admission in ICU [ Time Frame: 30 days ]
  • length of ICU stay more than 72 hours [ Time Frame: 30 days ]
  • Length of hospital stay [ Time Frame: 30 days ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title SEPSIS 3 Critera for Risk Stratification in Emergency Patients
Official Title Validation of the SEPSIS-3 Criterion for Sepsis and Septic Shock in the Emergency Department
Brief Summary

Investigators aim to evaluate the SEPSIS 3 criterion for "sepsis" and "septic shock" in a prospective manner.

Investigators will evaluate qSOFA performances and other SEPSIS 3 criterion in a population of emergency patients with infection

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Emergency patients with infection
Condition
  • Sepsis
  • Emergency
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Freund Y, Lemachatti N, Krastinova E, Van Laer M, Claessens YE, Avondo A, Occelli C, Feral-Pierssens AL, Truchot J, Ortega M, Carneiro B, Pernet J, Claret PG, Dami F, Bloom B, Riou B, Beaune S; French Society of Emergency Medicine Collaborators Group. Prognostic Accuracy of Sepsis-3 Criteria for In-Hospital Mortality Among Patients With Suspected Infection Presenting to the Emergency Department. JAMA. 2017 Jan 17;317(3):301-308. doi: 10.1001/jama.2016.20329.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 17, 2016)
879
Original Estimated Enrollment
 (submitted: April 8, 2016)
840
Actual Study Completion Date July 2016
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Adult that present to the emergency department
  • Diagnosis of infection by the treating emergency physician

Exclusion Criteria:

  • Refuse to participate
  • pregnancy
  • prisoner
  • Low acuity infection (localised, not requiring general treatment, without any abnormal vital parameters)
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Belgium,   France,   Spain,   Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number NCT02738164
Other Study ID Numbers SCREEN_SFMU
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Societe Française de Medecine d'urgence
Study Sponsor Societe Française de Medecine d'urgence
Collaborators Not Provided
Investigators
Principal Investigator: Yonathan Freund, MD, PhD SFMU
PRS Account Societe Française de Medecine d'urgence
Verification Date July 2016