French and EuRopean Outcome Registry in Intensive Care Unit

Completed

• Conditions: Tracheal Intubation Morbidity; Intensive Care Unit Syndrome

• Registration Number: NCT01367093
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Study First Submitted: 2011-05-27
• Study First Submitted QC: 2011-06-03
• Study First Posted: 2011-06-06
• Study Start: 2011-07
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Status Verified: 2017-04
• Last Update Submitted: 2017-05-02
• Last Update Posted: 2017-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2137

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
All cause mortality at one year after ICU discharge	one year

Secondary Outcome Measures

Name	Time	Method
To identify key determinants of cardiovascular morbidity and mortality in the year following a stay in ICU	one year
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
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
To assess quality of life in the year following a stay in ICU	one year
to evaluate social conditions	one year

Trial Locations

Locations (2)

St Louis hospital, department of intensive care; 🇫🇷 Paris, France

Department of Anesthesiology and Intensive Care Unit - Lariboisiere Hospital; 🇫🇷 Paris, France