French and EuRopean Outcome Registry in Intensive Care Unit

NCT ID: NCT01367093

Last Updated: 2017-05-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2137 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-07-31

Study Completion Date

2015-05-31

Brief Summary

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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

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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.

Conditions

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Intensive Care Unit Syndrome Tracheal Intubation Morbidity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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ICU patients admitted for severe illness

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alexandre Mebazaa, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

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Department of Anesthesiology and Intensive Care Unit - Lariboisiere Hospital

Paris, , France

Site Status

St Louis hospital, department of intensive care

Paris, , France

Site Status

Countries

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France

References

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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.

Reference Type RESULT
PMID: 26459405 (View on PubMed)

Borouchaki A, de Roquetaillade C, Boutin L, Gayat E, Mebazaa A, Chousterman BG. Association between serum uric acid level and outcome in intensive care unit, an ancillary analysis of the FROG-ICU cohort (URIC-ICU). Anaesth Crit Care Pain Med. 2025 Sep 29:101610. doi: 10.1016/j.accpm.2025.101610. Online ahead of print.

Reference Type DERIVED
PMID: 41033450 (View on PubMed)

Pharaboz A, Kimmoun A, Gunst J, Duarte K, Merkling T, Gayat E, Mebazaa A, Glenn-Chousterman B. Association between type II diabetes mellitus and 90-day mortality in a large multicenter prospectively collected cohort. A FROG ICU post-hoc study. J Crit Care. 2023 Feb;73:154195. doi: 10.1016/j.jcrc.2022.154195. Epub 2022 Oct 27.

Reference Type DERIVED
PMID: 36368176 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36207737 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35449071 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35278876 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34991653 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31678408 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31577804 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31567524 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30927096 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30353380 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29766216 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29347987 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23828026 (View on PubMed)

Other Identifiers

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2010-A01374-35

Identifier Type: OTHER

Identifier Source: secondary_id

NI10029

Identifier Type: -

Identifier Source: org_study_id

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