NCT02926664

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
512

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2016

Shorter than P25 for all trials

Geographic Reach
3 countries

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

October 5, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 6, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

October 24, 2017

Status Verified

October 1, 2017

Enrollment Period

7 months

First QC Date

October 5, 2016

Last Update Submit

October 21, 2017

Conditions

Sepsis

Outcome Measures

Primary Outcomes (1)

  • In-hospital mortality

    60 days

Secondary Outcomes (2)

  • ICU admission more than 72 hours

    60 days

  • ICU admission

    60 days

Interventions

measurement of qSOFAOTHER

qSOFA will be measured at H0, H1 and H3

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • Infection ruled out by the expert after chart review
  • patient who refuse to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Cliniques St Luc

Brussels, Belgium

Location

CHU Nimes

Nîmes, France

Location

Cochin

Paris, France

Location

Hopital Europeen Georges Pompidou

Paris, France

Location

Hopital Pitié-Salpêtrière

Paris, France

Location

Hopital Tenon

Paris, France

Location

Lariboisière

Paris, France

Location

Saint Antoine

Paris, France

Location

CHU Strasbourg

Strasbourg, France

Location

Hospital Clinic

Barcelona, Spain

Location

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Yonathan Freund

    Emergency Department - hopital pitie salpetriere, Paris, France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

October 5, 2016

First Posted

October 6, 2016

Study Start

October 1, 2016

Primary Completion

May 1, 2017

Study Completion

May 1, 2017

Last Updated

October 24, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will share

data will be available upon request to the principal investigator

Locations

BE(1)FR(8)ES(1)