Hospital Orientation Since SAMU Regulation Centre Call | NCT03237403

Studies
Hospital Orientation Since SAMU Regulation Centre Call

NCT03237403

Sponsor

Hôpital Necker-Enfants Malades

Status

Unknown status

Last Update Posted

Aug 3, 2017Actual

Enrollment

1,000Estimated

Phase

Not provided

Conditions

Sepsis

Interventions

observational study

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2017Actual

Primary Completion Date

Jan 1, 2019Estimated

Completion Date

Jan 1, 2019Estimated

First Submitted Date

Jul 31, 2017

First Submission Date that Met QC Criteria

Jul 31, 2017

First Posted Date

Aug 2, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 1, 2017

Last Update Posted Date

Aug 3, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Romain Jouffroy, Principal Investigator, Hôpital Necker-Enfants MaladesPrincipal Investigator

Lead Sponsor

Hôpital Necker-Enfants MaladesOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Anonymous, descriptive, longitudinal, resting study searching an association between clinical criteria transmitted by non-medical emergency services to the regulation of the SAMU centre call for patients with suspected sepsis and their subsequent hospital orientation

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,000Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
observational study	Other	observational study between clinical criteria collected at SAMU regulation centre call and hospital orientation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Hospital Admission Service	Emergency department or intensive care unit	1 day

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria: minor (age<18years)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Romain Jouffroy, MD	Contact	+3314495989		romain.jouffroy@aphp.fr
Benoit Vivien, MD, PhD	Contact	+33144492424		benoit.vivien@aphp.fr

Overall Officials

Name	Affiliation	Role
Romain Jouffroy, MD	APHP Necker Enfants Malades SAMU 75	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
APHP Necker Enfants Malades	Recruiting	Paris		75015	France

IPD Sharing Statement Module

Plan to Share IPD

Description

No IPD sharing plan is planned

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D018805	Sepsis

Ancestor Terms

ID	Term
D007239	Infections
D018746	Systemic Inflammatory Response Syndrome
D007249	Inflammation
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019370	Observation

Ancestor Terms

ID	Term
D008722	Methods
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided