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Intensive Care Unit SyndromeFROG-ICUNCT01367093

French and EuRopean Outcome Registry in Intensive Care Unit

An observational study of Intensive Care Unit Syndrome and Tracheal Intubation Morbidity, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
How many people
2,137 participants
Where
2 sitesFrance
Study dates
Jul 2011to May 2015
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: ICU patients admitted for severe illness those who are at risk of death in the year following the discharge from ICU.

Who may be able to join

  • 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

Who cannot join

  • age < 18 years
  • pregnancy women
  • Breast-feeding women
  • Not affiliated with social security
  • Dying man
  • End of life patient
Show all 13Show fewer
  • 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

Trial locations and contacts

2 sites in 1 country.

France2 sites

  • Department of Anesthesiology and Intensive Care Unit - Lariboisiere Hospital

    Paris, 75010

  • St Louis hospital, department of intensive care

    Paris, 75010

Other trials in France

About this study

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.

Read the 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.

Keywords
BIOLOGICAL MARKERS, INTENSIVE CARE UNIT, MORTALITY, QUALITY OF LIFE, CARDIOVASCULAR

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01367093
Study groupRoleWhat they receive
ICU patients admitted for severe illnessNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. All cause mortality at one year after ICU discharge

    Measured: one year

Secondary outcomes (5)

  1. To assess quality of life in the year following a stay in ICU

    Measured: one year

  2. To identify key determinants of cardiovascular morbidity and mortality in the year following a stay in ICU

    Measured: one year

  3. 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.

    Measured: one year

  4. 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.

    Measured: one year

  5. to evaluate social conditions

    Measured: one year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jun 2011 (estimated)
  2. Study startJul 2011
  3. Primary completionMay 2015
  4. Study completionMay 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
2,137 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01367093
Sponsor's protocol ID
NI10029
Other IDs
2010-A01374-35
Acronym
FROG-ICU
Status last verified
Apr 2017
First submitted
27 May 2011
Last updated
5 May 2017
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 26459405

  • Blet A, Walter-Petrich A, Cherifa M, Bruno J, Tran Dinh A, Azoulay E, Chousterman B, Cotter G, Davison B, Deniau B, Gayat E, Guidet B, Harrois A, Kimmoun A, Leone M, Wittebole X, Ambrosy AP, Mebazaa A, Resche-Rigon M. Survival after ICU discharge is shaped more by chronic disease than admission severity. J Crit Care. 2026 Apr;92:155401. doi: 10.1016/j.jcrc.2025.155401. Epub 2025 Dec 10.

    PubMed 41380507

  • 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 Nov;44(6):101610. doi: 10.1016/j.accpm.2025.101610. Epub 2025 Sep 29.

    PubMed 41033450

  • Boutin L, Latosinska A, Mischak H, Deniau B, Asakage A, Legrand M, Gayat E, Mebazaa A, Chadjichristos CE, Depret F. Subclinical and clinical acute kidney injury share similar urinary peptide signatures and prognosis. Intensive Care Med. 2023 Oct;49(10):1191-1202. doi: 10.1007/s00134-023-07198-2. Epub 2023 Sep 5.

    PubMed 37670154

  • 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.

    PubMed 36368176

  • 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.

    PubMed 36207737

  • 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.

    PubMed 35449071

  • 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.

    PubMed 35278876

  • 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.

    PubMed 34991653

  • 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.

    PubMed 31678408

  • 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.

    PubMed 31577804

  • 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.

    PubMed 31567524

  • 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.

    PubMed 30927096

  • 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.

    PubMed 30353380

  • 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.

    PubMed 29766216

Questions about this trial

What is this clinical trial studying?

An observational study of Intensive Care Unit Syndrome and Tracheal Intubation Morbidity, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

All cause mortality at one year after ICU discharge (time frame: one year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01367093, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2017.

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