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French and EuRopean Outcome Registry in Intensive Care Unit (FROG-ICU)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01367093
First Posted: June 6, 2011
Last Update Posted: May 5, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
  Purpose
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.

Condition
Intensive Care Unit Syndrome Tracheal Intubation Morbidity

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: French and EuRopean Outcome Registry in Intensive Care Unit

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • All cause mortality at one year after ICU discharge [ Time Frame: one year ]

Secondary Outcome Measures:
  • To assess quality of life in the year following a stay in ICU [ Time Frame: one year ]
  • To identify key determinants of cardiovascular morbidity and mortality in the year following a stay in ICU [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: one year ]
  • to evaluate social conditions [ Time Frame: one year ]

Biospecimen Retention:   Samples Without DNA
Plasma and urine at admission and ICU discharge

Enrollment: 2137
Study Start Date: July 2011
Study Completion Date: May 2015
Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
ICU patients admitted for severe illness

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
ICU patients admitted for severe illness those who are at risk of death in the year following the discharge from ICU.
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01367093


Locations
France
Department of Anesthesiology and Intensive Care Unit - Lariboisiere Hospital
Paris, France, 75010
St Louis hospital, department of intensive care
Paris, France, 75010
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Alexandre Mebazaa, MD, PhD Assistance Publique - Hôpitaux de Paris
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01367093     History of Changes
Other Study ID Numbers: NI10029
2010-A01374-35 ( Other Identifier: IDRCB )
First Submitted: May 27, 2011
First Posted: June 6, 2011
Last Update Posted: May 5, 2017
Last Verified: April 2017

Keywords provided by Assistance Publique - Hôpitaux de Paris:
BIOLOGICAL MARKERS
INTENSIVE CARE UNIT
MORTALITY
QUALITY OF LIFE
CARDIOVASCULAR