Trial record 16 of 324 for:
Open Studies | "Intensive Care"
French and EuRopean Outcome Registry in Intensive Care Unit (FROG-ICU)
This study is currently recruiting participants.
Verified March 2013 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Assistance Publique - Hôpitaux de Paris
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01367093
First received: May 27, 2011
Last updated: March 26, 2013
Last verified: March 2013
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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 ]
Biospecimen Retention: Samples Without DNA
Plasma and urine at admission and ICU discharge
| Estimated Enrollment: | 3262 |
| 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
- and discharged alive from ICU
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01367093
Contacts
| Contact: Alexandre MEBAZAA, PhD, MD | +33(0)1 49 95 80 71 | alexandre.mebazaa@lrb.aphp.fr |
| Contact: Marie-Céline Fournier | +33(0)1 53 21 66 81 | frog.icu@lrb.aphp.fr |
Locations
| France | |
| Department of Anesthesiology and Intensive Care Unit - Lariboisiere Hospital | Recruiting |
| Paris, France, 75010 | |
| Contact: Alexandre Mebazaa, MD, PhD +33(0)149958071 alexandre.mebazaa@lrb.aphp.fr | |
| Principal Investigator: Alexandre Mebazaa, PhD, MD | |
| St Louis hospital, department of intensive care | Recruiting |
| Paris, France, 75010 | |
| Contact: Anne-Sophie Moreau, MD | |
| Principal Investigator: Anne-Sophie Moreau, MD | |
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
| 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: | March 26, 2013 |
| 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 May 16, 2013