French and EuRopean Outcome Registry in Intensive Care Unit | NCT01367093

Studies
French and EuRopean Outcome Registry in Intensive Care Unit

NCT01367093

Sponsor

Assistance Publique - Hôpitaux de Paris

Status

Completed

Last Update Posted

May 5, 2017Actual

Enrollment

2,137Actual

Phase

Not provided

Conditions

Intensive Care Unit Syndrome
Tracheal Intubation Morbidity

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

ID	Type	Description	Link
2010-A01374-35	Other Identifier	IDRCB

Status Module

Record Verification Date

Apr 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2011

Primary Completion Date

May 2015Actual

Completion Date

May 2015Actual

First Submitted Date

May 27, 2011

First Submission Date that Met QC Criteria

Jun 3, 2011

First Posted Date

Jun 6, 2011Estimated

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

May 2, 2017

Last Update Posted Date

May 5, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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 purpose of this study is to identify within a cohort of ICU patients admitted for severe illness those who are at risk of death in the year following the discharge from ICU.

Detailed Description

FROG-ICU is an epidemiological, observational, prospective, multi centric, cohort study designed for description, prognostic and evaluation. This trial includes as a first step a complete registry of patients admitted to the ICU and as a second step, the outcome of the patients at 1 year after they have been discharged alive from ICU.

Plasma and urine samples will be with drawn biomarkers measurements at admission and ICU discharge. It is a multicentric study involving 1 center in Belgium et 24 centers in France.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

2,137Actual

Label	Type	Description	Intervention Names
ICU patients admitted for severe illness

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
All cause mortality at one year after ICU discharge		one year

Secondary Outcomes

Measure	Description	Time Frame
To assess quality of life in the year following a stay in ICU		one year
To identify key determinants of cardiovascular morbidity and mortality in the year following a stay in ICU		one year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Adult patients hospitalized in ICU
Patients should have been intubated more than 24 hours
or treated with a positive inotropic agent for more than 24 hours (if not ventilated

Exclusion Criteria:

age < 18 years
pregnancy women
Breast-feeding women
Not affiliated with social security
Dying man
End of life patient
Traumatic Brain Injury (IGCS < 8)
NTBR
vegetative coma
Transplanted for less than year
no french speaking patient
out of france resident
end of life decision during the following

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

ICU patients admitted for severe illness those who are at risk of death in the year following the discharge from ICU.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Alexandre Mebazaa, MD, PhD	Assistance Publique - Hôpitaux de Paris	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Anesthesiology and Intensive Care Unit - Lariboisiere Hospital		Paris		75010	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26459405	Result	Mebazaa A, Casadio MC, Azoulay E, Guidet B, Jaber S, Levy B, Payen D, Vicaut E, Resche-Rigon M, Gayat E. Post-ICU discharge and outcome: rationale and methods of the The French and euRopean Outcome reGistry in Intensive Care Units (FROG-ICU) observational study. BMC Anesthesiol. 2015 Oct 12;15:143. doi: 10.1186/s12871-015-0129-2.
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