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Clinical Trials/NCT01367093
NCT01367093
Completed
Not Applicable

French and EuRopean Outcome Registry in Intensive Care Unit

Assistance Publique - Hôpitaux de Paris2 sites in 1 country2,137 target enrollmentJuly 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Intensive Care Unit Syndrome
Sponsor
Assistance Publique - Hôpitaux de Paris
Enrollment
2137
Locations
2
Primary Endpoint
All cause mortality at one year after ICU discharge
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 2011
End Date
May 2015
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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)
  • vegetative coma
  • Transplanted for less than year
  • no french speaking patient

Outcomes

Primary Outcomes

All cause mortality at one year after ICU discharge

Time Frame: one year

Secondary Outcomes

  • 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)

Study Sites (2)

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