French and EuRopean Outcome Registry in Intensive Care Unit

Intensive Care Unit Syndrome Clinical Trial

— FROG-ICU  

Official title:

French and EuRopean Outcome Registry in Intensive Care Unit

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01367093
• Other study ID #: NI10029
• Secondary ID: 2010-A01374-35
• Status: Completed
• Phase: N/A
• First received: May 27, 2011
• Last updated: May 2, 2017
• Start date: July 2011
• Est. completion date: May 2015

Study information

• Verified date: April 2017
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2137
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Intensive Care Unit Syndrome
• Tracheal Intubation Morbidity

Locations

Country	Name	City	State
France	Department of Anesthesiology and Intensive Care Unit - Lariboisiere Hospital	Paris
France	St Louis hospital, department of intensive care	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All cause mortality at one year after ICU discharge		one year
Secondary	To assess quality of life in the year following a stay in ICU		one year
Secondary	To identify key determinants of cardiovascular morbidity and mortality in the year following a stay in ICU		one year
Secondary	To investigate the performance of plasma biomarkers usually measured in ICU, to assess the risk of death during the stay in ICU and one year after the discharge.		one year
Secondary	To set up a biological collection of plasma and urine, in order to measure new plasma biomarkers in the assessment of prognosis in the year following a stay in ICU.		one year
Secondary	to evaluate social conditions		one year