Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2025-12-28 @ 12:03 AM
Study NCT ID:
NCT01367093
Status:
COMPLETED
Last Update Posted:
2017-05-05
First Post:
2011-05-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
French and EuRopean Outcome Registry in Intensive Care Unit
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Plasma and urine at admission and ICU discharge'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2137}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-02', 'studyFirstSubmitDate': '2011-05-27', 'studyFirstSubmitQcDate': '2011-06-03', 'lastUpdatePostDateStruct': {'date': '2017-05-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-06-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'All cause mortality at one year after ICU discharge', 'timeFrame': 'one year'}], 'secondaryOutcomes': [{'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'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['BIOLOGICAL MARKERS', 'INTENSIVE CARE UNIT', 'MORTALITY', 'QUALITY OF LIFE', 'CARDIOVASCULAR'], 'conditions': ['Intensive Care Unit Syndrome', 'Tracheal Intubation Morbidity']}, 'referencesModule': {'references': [{'pmid': '26459405', 'type': 'RESULT', '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.'}, {'pmid': '41380507', 'type': 'DERIVED', 'citation': '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. 2025 Dec 10;92:155401. doi: 10.1016/j.jcrc.2025.155401. Online ahead of print.'}, {'pmid': '41033450', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '36368176', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '36207737', 'type': 'DERIVED', '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."}, {'pmid': '35449071', 'type': 'DERIVED', '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.'}, {'pmid': '35278876', 'type': 'DERIVED', '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.'}, {'pmid': '34991653', 'type': 'DERIVED', '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.'}, {'pmid': '31678408', 'type': 'DERIVED', '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.'}, {'pmid': '31577804', 'type': 'DERIVED', '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.'}, {'pmid': '31567524', 'type': 'DERIVED', '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.'}, {'pmid': '30927096', 'type': 'DERIVED', '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.'}, {'pmid': '30353380', 'type': 'DERIVED', '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.'}, {'pmid': '29766216', 'type': 'DERIVED', '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.'}, {'pmid': '29347987', 'type': 'DERIVED', '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.'}, {'pmid': '23828026', 'type': 'DERIVED', '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."}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nPlasma 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'ICU patients admitted for severe illness those who are at risk of death in the year following the discharge from ICU.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Adult patients hospitalized in ICU\n* Patients should have been intubated more than 24 hours\n* or treated with a positive inotropic agent for more than 24 hours (if not ventilated\n\nExclusion Criteria:\n\n* age \\< 18 years\n* pregnancy women\n* Breast-feeding women\n* Not affiliated with social security\n* Dying man\n* End of life patient\n* Traumatic Brain Injury (IGCS \\< 8)\n* NTBR\n* vegetative coma\n* Transplanted for less than year\n* no french speaking patient\n* out of france resident\n* end of life decision during the following'}, 'identificationModule': {'nctId': 'NCT01367093', 'acronym': 'FROG-ICU', 'briefTitle': 'French and EuRopean Outcome Registry in Intensive Care Unit', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'French and EuRopean Outcome Registry in Intensive Care Unit', 'orgStudyIdInfo': {'id': 'NI10029'}, 'secondaryIdInfos': [{'id': '2010-A01374-35', 'type': 'OTHER', 'domain': 'IDRCB'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'ICU patients admitted for severe illness'}]}, 'contactsLocationsModule': {'locations': [{'zip': '75010', 'city': 'Paris', 'country': 'France', 'facility': 'Department of Anesthesiology and Intensive Care Unit - Lariboisiere Hospital', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75010', 'city': 'Paris', 'country': 'France', 'facility': 'St Louis hospital, department of intensive care', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Alexandre Mebazaa, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}