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

May 2, 2017 updated by: Assistance Publique - Hôpitaux de Paris
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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

2137

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75010
        • Department of Anesthesiology and Intensive Care Unit - Lariboisiere Hospital
      • Paris, France, 75010
        • St Louis hospital, department of intensive care

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
ICU patients admitted for severe illness

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
All cause mortality at one year after ICU discharge
Time Frame: one year
one year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Alexandre MEBAZAA, MD, PhD, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

May 27, 2011

First Submitted That Met QC Criteria

June 3, 2011

First Posted (Estimate)

June 6, 2011

Study Record Updates

Last Update Posted (Actual)

May 5, 2017

Last Update Submitted That Met QC Criteria

May 2, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • NI10029
  • 2010-A01374-35 (Other Identifier: IDRCB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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