NCT03237403

Brief Summary

Specify the association between clinical criteria transmitted by non-medical emergency services to the regulation of the SAMU centre call in patients with suspected sepsis and their hospital orientation: emergency department or intensive care unit

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

1 active site

Status
unknown

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

January 1, 2017

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 31, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 2, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

August 3, 2017

Status Verified

August 1, 2017

Enrollment Period

2 years

First QC Date

July 31, 2017

Last Update Submit

August 1, 2017

Conditions

Sepsis

Keywords

SepsisAdultsPre hospital settingsTriageHospital orientationOutcome

Outcome Measures

Primary Outcomes (1)

  • Hospital Admission Service

    Emergency department or intensive care unit

    1 day

Interventions

observational studyOTHER

observational study between clinical criteria collected at SAMU regulation centre call and hospital orientation

Eligibility Criteria

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

All subjects calling the SAMU regulation centre call with a clinical suspected sepsis history

You may qualify if:

  • adults (age\>18years)
  • patients with suspected sepsis state at the regulation SAMU centre call

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

APHP Necker Enfants Malades

Paris, 75015, France

RECRUITING

MeSH Terms

Conditions

Sepsis

Interventions

Observation

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Romain Jouffroy, MD

    APHP Necker Enfants Malades SAMU 75

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Romain Jouffroy, MD

CONTACT

+3314495989romain.jouffroy@aphp.fr

Benoit Vivien, MD, PhD

CONTACT

+33144492424benoit.vivien@aphp.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 31, 2017

First Posted

August 2, 2017

Study Start

January 1, 2017

Primary Completion

January 1, 2019

Study Completion

January 1, 2019

Last Updated

August 3, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share

No IPD sharing plan is planned

Locations

FR(1)