Clinical trial NCT01367093: French and EuRopean Outcome Registry in Intensive Care Unit
Official title: French and EuRopean Outcome Registry in Intensive Care Unit
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intensive Care Unit Syndrome
Tracheal Intubation Morbidity
Keywords: BIOLOGICAL MARKERS
INTENSIVE CARE UNIT
MORTALITY
QUALITY OF LIFE
CARDIOVASCULAR
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2011-06-06
Enrollment: 2137
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: 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.

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 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

Primary outcomes:
measure: All cause mortality at one year after ICU discharge
timeFrame: one year
Secondary outcomes:
measure: To assess quality of life in the year following a stay in ICU
timeFrame: one year
measure: To identify key determinants of cardiovascular morbidity and mortality in the year following a stay in ICU
timeFrame: one year
measure: 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.
timeFrame: one year
measure: 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.
timeFrame: one year
measure: to evaluate social conditions
timeFrame: one year
Other outcomes:
Locations:
city: Paris
country: France
facility: Department of Anesthesiology and Intensive Care Unit - Lariboisiere Hospital
city: Paris
country: France
facility: St Louis hospital, department of intensive care
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Alexandre Mebazaa, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mebazaa A, Casadio MC, Azoulay E, Guidet B, Jaber S, Levy B, Payen D, Vicaut E, Resche-Rigon M, Gayat E. Post-ICU discharge and outcome: rationale and methods of the The French and euRopean Outcome reGistry in Intensive Care Units (FROG-ICU) observational study. BMC Anesthesiol. 2015 Oct 12;15:143. doi: 10.1186/s12871-015-0129-2.
citation: Blet A, McNeil JB, Josse J, Cholley B, Cinotti R, Cotter G, Dauvergne A, Davison B, Duarte K, Duranteau J, Fournier MC, Gayat E, Jaber S, Lasocki S, Merkling T, Peoc'h K, Mayer I, Sadoune M, Laterre PF, Sonneville R, Ware L, Mebazaa A, Kimmoun A. Association between in-ICU red blood cells transfusion and 1-year mortality in ICU survivors. Crit Care. 2022 Oct 7;26(1):307. doi: 10.1186/s13054-022-04171-1.
citation: Soussi S, Sharma D, Juni P, Lebovic G, Brochard L, Marshall JC, Lawler PR, Herridge M, Ferguson N, Del Sorbo L, Feliot E, Mebazaa A, Acton E, Kennedy JN, Xu W, Gayat E, Dos Santos CC; FROG-ICU; CCCTBG trans-trial group study for InFACT - the International Forum for Acute Care Trialists. Identifying clinical subtypes in sepsis-survivors with different one-year outcomes: a secondary latent class analysis of the FROG-ICU cohort. Crit Care. 2022 Apr 21;26(1):114. doi: 10.1186/s13054-022-03972-8.
citation: Takagi K, Akiyama E, Paternot A, Miro O, Charron C, Gayat E, Deye N, Cariou A, Monnet X, Jaber S, Guidet B, Damoisel C, Barthelemy R, Azoulay E, Kimmoun A, Fournier MC, Cholley B, Edwards C, Davison BA, Cotter G, Vieillard-Baron A, Mebazaa A. Early echocardiography by treating physicians and outcome in the critically ill: An ancillary study from the prospective multicenter trial FROG-ICU. J Crit Care. 2022 Jun;69:154013. doi: 10.1016/j.jcrc.2022.154013. Epub 2022 Mar 9.
citation: Boutin L, Legrand M, Sadoune M, Mebazaa A, Gayat E, Chadjichristos CE, Depret F. Elevated plasma Galectin-3 is associated with major adverse kidney events and death after ICU admission. Crit Care. 2022 Jan 6;26(1):13. doi: 10.1186/s13054-021-03878-x.
citation: Kimmoun A, Cariou A, Gayat E, Feliot E, Takagi K, Megarbane B, Mebazaa A, Deye N; FROG-ICU Study investigators. One-year outcome of patients admitted after cardiac arrest compared to other causes of ICU admission. An ancillary analysis of the observational prospective and multicentric FROG-ICU study. Resuscitation. 2020 Jan 1;146:237-246. doi: 10.1016/j.resuscitation.2019.10.021. Epub 2019 Oct 31.
citation: Cinotti R, Voicu S, Jaber S, Chousterman B, Paugam-Burtz C, Oueslati H, Damoisel C, Caillard A, Roquilly A, Feuillet F, Mebazaa A, Gayat E; FROG-ICU investigators. Tracheostomy and long-term mortality in ICU patients undergoing prolonged mechanical ventilation. PLoS One. 2019 Oct 2;14(10):e0220399. doi: 10.1371/journal.pone.0220399. eCollection 2019.
citation: Legrand M, Hollinger A, Vieillard-Baron A, Depret F, Cariou A, Deye N, Fournier MC, Jaber S, Damoisel C, Lu Q, Monnet X, Rennuit I, Darmon M, Zafrani L, Leone M, Guidet B, Friedman D, Sonneville R, Montravers P, Pili-Floury S, Lefrant JY, Duranteau J, Laterre PF, Brechot N, Oueslati H, Cholley B, Launay JM, Ishihara S, Sato N, Mebazaa A, Gayat E; French and euRopean Outcome reGistry in ICUs (FROG-ICU) Investigators. One-Year Prognosis of Kidney Injury at Discharge From the ICU: A Multicenter Observational Study. Crit Care Med. 2019 Dec;47(12):e953-e961. doi: 10.1097/CCM.0000000000004010.
citation: Hollinger A, Gayat E, Feliot E, Paugam-Burtz C, Fournier MC, Duranteau J, Lefrant JY, Leone M, Jaber S, Mebazaa A, Arrigo M; FROG ICU study investigators. Gender and survival of critically ill patients: results from the FROG-ICU study. Ann Intensive Care. 2019 Mar 29;9(1):43. doi: 10.1186/s13613-019-0514-y.
citation: Bastian K, Hollinger A, Mebazaa A, Azoulay E, Feliot E, Chevreul K, Fournier MC, Guidet B, Michel M, Montravers P, Pili-Floury S, Sonneville R, Siegemund M, Gayat E; FROG-ICU Study Investigators. Association of social deprivation with 1-year outcome of ICU survivors: results from the FROG-ICU study. Intensive Care Med. 2018 Dec;44(12):2025-2037. doi: 10.1007/s00134-018-5412-5. Epub 2018 Oct 23.
citation: Gayat E, Hollinger A, Cariou A, Deye N, Vieillard-Baron A, Jaber S, Chousterman BG, Lu Q, Laterre PF, Monnet X, Darmon M, Leone M, Guidet B, Sonneville R, Lefrant JY, Fournier MC, Resche-Rigon M, Mebazaa A, Legrand M; FROG-ICU investigators. Impact of angiotensin-converting enzyme inhibitors or receptor blockers on post-ICU discharge outcome in patients with acute kidney injury. Intensive Care Med. 2018 May;44(5):598-605. doi: 10.1007/s00134-018-5160-6. Epub 2018 May 15.
citation: Gayat E, Cariou A, Deye N, Vieillard-Baron A, Jaber S, Damoisel C, Lu Q, Monnet X, Rennuit I, Azoulay E, Leone M, Oueslati H, Guidet B, Friedman D, Tesniere A, Sonneville R, Montravers P, Pili-Floury S, Lefrant JY, Duranteau J, Laterre PF, Brechot N, Chevreul K, Michel M, Cholley B, Legrand M, Launay JM, Vicaut E, Singer M, Resche-Rigon M, Mebazaa A. Determinants of long-term outcome in ICU survivors: results from the FROG-ICU study. Crit Care. 2018 Jan 18;22(1):8. doi: 10.1186/s13054-017-1922-8.
citation: 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. No abstract available.