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French and EuRopean Outcome Registry in Intensive Care Unit

French and EuRopean Outcome Registry in Intensive Care Unit

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01367093
Acronym
FROG-ICU
Enrollment
2137
Registered
2011-06-06
Start date
2011-07-31
Completion date
2015-05-31
Last updated
2017-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intensive Care Unit Syndrome, Tracheal Intubation Morbidity

Keywords

BIOLOGICAL MARKERS, INTENSIVE CARE UNIT, MORTALITY, QUALITY OF LIFE, CARDIOVASCULAR

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.

Interventions

None listed

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
All cause mortality at one year after ICU dischargeone year

Secondary

MeasureTime frame
To assess quality of life in the year following a stay in ICUone year
To identify key determinants of cardiovascular morbidity and mortality in the year following a stay in ICUone 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 evaluate social conditionsone year

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 15, 2026