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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01367093
First received: May 27, 2011
Last updated: May 30, 2014
Last verified: May 2014
  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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess quality of life in the year following a stay in ICU [ Time Frame: one year ] [ Designated as safety issue: No ]
  • To identify key determinants of cardiovascular morbidity and mortality in the year following a stay in ICU [ Time Frame: one year ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • to evaluate social conditions [ Time Frame: one year ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Plasma and urine at admission and ICU discharge


Enrollment: 2137
Study Start Date: July 2011
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Assistance Publique - Hôpitaux de Paris

Additional 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
Study First Received: May 27, 2011
Last Updated: May 30, 2014
Health Authority: France: Ministry of Health

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

ClinicalTrials.gov processed this record on October 19, 2014