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Completed

NCT Number: NCT01367093

French and EuRopean Outcome Registry in Intensive Care Unit

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.

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Key information

Conditions

Intensive Care Unit Syndrome Tracheal Intubation Morbidity

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. All cause mortality at one year after ICU discharge

    Time frame: one year

Secondary outcomes

  1. To assess quality of life in the year following a stay in ICU

    Time frame: one year

  2. To identify key determinants of cardiovascular morbidity and mortality in the year following a stay in ICU

    Time frame: one year

  3. 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.

    Time frame: one year

  4. 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.

    Time frame: one year

  5. to evaluate social conditions

    Time frame: one year

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Acronym: FROG-ICU

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Jun 6, 2011
Registry last updated
May 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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