FROG-ICU - Cohort of Patients Admitted to Intensive Care for Serious Illnesses: Study on Mortality Risk Factors Up to One Year
Head :
Mebazaa Alexandre, UMR-S 942 Inserm
Gerard Sophie, Lariboisière Clinical Research Unit
Gerard Sophie, Lariboisière Clinical Research Unit
Last update : 08/17/2016 | Version : 1 | ID : 73036
| General | |
| Identification | |
| Detailed name | Cohort of Patients Admitted to Intensive Care for Serious Illnesses: Study on Mortality Risk Factors Up to One Year |
| Sign or acronym | FROG-ICU |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CCTIRS ref. 11134 on 10/03/11 CNIL authorisation 30/06/11 under no. 911169 CPP 15/03/11 under ref. 2011/05NI; Clinical Trials.gov NCT01367093. Biological collection declaration at the ministry 21/06/12. |
| General Aspects | |
| Medical area |
Anesthesiology – Intensive care |
| Health determinants |
Healthcare system and access to health care services Iatrogenic Lifestyle and behavior |
| Keywords | intensive care, SF36, serious illness, mortality, morbidity, quality of life |
| Scientific investigator(s) (Contact) | |
| Name of the director | Mebazaa |
| Surname | Alexandre |
| Phone | +33 (0)1 53 21 67 60 |
| alexandre.mebazaa@lrb.aphp.fr | |
| Unit | UMR-S 942 Inserm |
| Organization | Paris Public Hospitals |
| Name of the director | Gerard |
| Surname | Sophie |
| Phone | +33 (0) 1 40 45 49 85 |
| sophie.gerard@lrb.aphp.fr | |
| Unit | Lariboisière Clinical Research Unit |
| Organization | AP-HP |
| Collaborations | |
| Funding | |
| Funding status |
Public |
| Details | AP-HP (Paris Public Hospitals) |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | Assistance Publique - Hôpitaux de Paris |
| Organisation status |
Public |
| Presence of scientific or steering committees |
Yes |
| Additional contact | |
| Main features | |
| Type of database | |
| Type of database |
Study databases |
| Study databases (details) |
Cohort study |
| Database recruitment is carried out by an intermediary |
A selection of health institutions and services |
| Database recruitment is is made on the basis of: |
Another treatment or procedure |
| Additional information regarding sample selection. | 21 centres throughout France and Belgium. |
| Database objective | |
| Main objective | This study aims to identify the risk factors of mortality within a cohort of patients during the year following discharge from the intensive care unit. |
| Inclusion criteria |
Adult patients admitted to the ICU.
Patients must be intubated for at least 24 hrs or treated with an inotropic agent. |
| Population type | |
| Age |
Adulthood (19 to 24 years) Adulthood (25 to 44 years) Adulthood (45 to 64 years) Elderly (65 to 79 years) Great age (80 years and more) |
| Population covered |
Sick population |
| Gender |
Male Woman |
| Geography area |
National |
| Detail of the geography area | France and Belgium |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 2011 |
| Size of the database | |
| Size of the database (number of individuals) |
[1000-10 000[ individuals |
| Details of the number of individuals | 2,136 |
| Data | |
| Database activity |
Data collection completed |
| Type of data collected |
Clinical data Declarative data Biological data |
| Declarative data (detail) |
Paper self-questionnaire Face to face interview |
| Details of collected declarative data | Quality of life analysis (SF36) |
| Presence of a biobank |
Yes |
| Details of biobank content | Yes; managed by the Lariboisière CRB (Centre de ressources biologiques [biological resource centre]) |
| Health parameters studied |
Health event/mortality Quality of life/health perception |
| Procedures | |
| Data collection method | Data collected in an eCRF designed by the St. Louis DBIM (data and biostatistics unit), monitoring carried out by the Lariboisière Clinical Research unit; queries published and resolved. |
| Participant monitoring |
Yes |
| Details on monitoring of participants | Follow-up at 3/6/12 months |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Link to the document | Legrand M, Januzzi JL Jr, Mebazaa A. Critical research on biomarkers: what's new? Intensive Care Med. 2013 Oct;39(10):1824-8. doi: 10.1007/s00134-013-3008-7. Epub 2013 Jul 5. |
| Link to the document | http://tinyurl.com/PUBMED-FROG-ICU |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | Access to database through login and code for site users and coordinating team (DBIM, URC, Mebazaa team). |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
