Community Acquired Sepsis Cohort | NCT03280992

Studies
Community Acquired Sepsis Cohort

NCT03280992

Sponsor

Rennes University Hospital

Status

Terminated

Last Update Posted

Dec 2, 2021Actual

Enrollment

796Actual

Phase

Not provided

Conditions

Severe Septic Syndrome
Septic Shock

Interventions

Not provided

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

Dec 2021

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study not feasible in practise

Expanded Access Info

Start Date

Mar 2, 2016Actual

Primary Completion Date

Aug 27, 2018Actual

Completion Date

Aug 27, 2018Actual

First Submitted Date

Aug 18, 2017

First Submission Date that Met QC Criteria

Sep 12, 2017

First Posted Date

Sep 13, 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

Dec 1, 2021

Last Update Posted Date

Dec 2, 2021Actual

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

The aim of this project is to constitute a prospective cohort of all the patients presenting to the adult emergencies of the University Hospital Centre (CHU) of Rennes for a septic syndrome of community origin.

Detailed Description

Severe septic syndrome (SSG) and septic shock (CS) are two frequent and serious complications of infectious diseases. In this context, the optimization of the management of septic patients from their reception in the emergency services must be a priority. However there are no predictors of progression or severity in patients admitted to emergencies despite the recommendations emphasizing the need for screening and early therapeutic management. Many scores have been proposed for intensive care unit but they remain difficult to extrapolate to other services because they are very comprehensive and require information that is difficult to obtain for emergency physicians.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

3 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

796Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Assessment of morbidity in patients with septic syndrome of community origin	Study of prognostic factors	Day 90
Internal validity, severity score		Day 90
Internal validity, triage score by orientation nurses		Day 90
Study of the prognostic factors of patients with septic syndrome of community origin in terms of mortality		Day 90

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient older than 18 years old
Patient hospitalized during the study period for community infectious diseases at the CHU of Rennes

Exclusion Criteria:

Written objection from the patient to the computer processing of his data
Pregnant women
Persons subject to major legal protection (safeguarding justice, guardianship, trusteeship), persons deprived of liberty

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

Patient with a community infectious diseases

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
CHU de Rennes		Rennes		35033	France

Condition Browse Module

MeSH Terms

ID	Term
D014115	Toxemia
D012772	Shock, Septic

Ancestor Terms

ID	Term
D007239	Infections
D018805	Sepsis
D018746	Systemic Inflammatory Response Syndrome
D007249	Inflammation

Browse Leaves

Not provided

Browse Branches

Not provided