Ignite Creation Date:
2025-12-24 @ 3:35 PM
Ignite Modification Date:
2025-12-24 @ 3:35 PM
Study NCT ID:
NCT03370692
Status:
COMPLETED
Last Update Posted:
2021-04-28
First Post:
2017-12-07
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prognostic Score in the Very Old ICU Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3900}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2019-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-27', 'studyFirstSubmitDate': '2017-12-07', 'studyFirstSubmitQcDate': '2017-12-07', 'lastUpdatePostDateStruct': {'date': '2021-04-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Survival analysis in pre-defined subgroups: Admission categories, use of therapeutic procedures, end-of-life desicion', 'timeFrame': 'Up to 6 months', 'description': 'Proportions alive after 30 days and 6 months'}], 'primaryOutcomes': [{'measure': '30 days survival', 'timeFrame': '30 days', 'description': 'Proportion alive after 30 days'}], 'secondaryOutcomes': [{'measure': 'Developement of a prognostic score', 'timeFrame': '6 months', 'description': 'Developement and subsequent validation of a prognostic score from data revealed in the study: Frailty, Comorbidity, Activity of Daily life and Cognition. This score is non-existent at the moment, it is a score we will develope and test within the cohort-. No further description can be given before study is finished and analysed.'}, {'measure': '6 months survival', 'timeFrame': '6 months', 'description': 'Proportion alive after 6 months'}, {'measure': 'Inter-rater validation of Clinical Frailty Scale (CFS)', 'timeFrame': 'At admission', 'description': 'The CFS is a simple visual scale of frailty from 1 to 9 (increasing frailty). We will in a subset of our patients use two raters to perform frailty score and compare their results using inter-rater variability tests.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Outcome', 'Survival', 'Prognostication'], 'conditions': ['Aged, 80 and Over', 'Critical Care']}, 'referencesModule': {'references': [{'pmid': '38555336', 'type': 'DERIVED', 'citation': 'de Lange DW, Soliman IW, Leaver S, Boumendil A, Haas LEM, Watson X, Boulanger C, Szczeklik W, Artigas A, Morandi A, Andersen F, Jung C, Moreno R, Walther S, Oeyen S, Schefold JC, Cecconi M, Marsh B, Joannidis M, Nalapko Y, Elhadi M, Fjolner J, Guidet B, Flaatten H; VIP2 study group. The association of premorbid conditions with 6-month mortality in acutely admitted ICU patients over 80 years. Ann Intensive Care. 2024 Mar 30;14(1):46. doi: 10.1186/s13613-024-01246-w.'}, {'pmid': '37162595', 'type': 'DERIVED', 'citation': 'Mousai O, Tafoureau L, Yovell T, Flaatten H, Guidet B, Beil M, de Lange D, Leaver S, Szczeklik W, Fjolner J, Nachshon A, van Heerden PV, Joskowicz L, Jung C, Hyams G, Sviri S. The role of clinical phenotypes in decisions to limit life-sustaining treatment for very old patients in the ICU. Ann Intensive Care. 2023 May 10;13(1):40. doi: 10.1186/s13613-023-01136-7.'}, {'pmid': '36609257', 'type': 'DERIVED', 'citation': 'Beil M, van Heerden PV, de Lange DW, Szczeklik W, Leaver S, Guidet B, Flaatten H, Jung C, Sviri S, Joskowicz L. Contribution of information about acute and geriatric characteristics to decisions about life-sustaining treatment for old patients in intensive care. BMC Med Inform Decis Mak. 2023 Jan 6;23(1):1. doi: 10.1186/s12911-022-02094-z.'}, {'pmid': '35218366', 'type': 'DERIVED', 'citation': 'Guidet B, Jung C, Flaatten H, Fjolner J, Artigas A, Pinto BB, Schefold JC, Beil M, Sigal S, van Heerden PV, Szczeklik W, Joannidis M, Oeyen S, Kondili E, Marsh B, Andersen FH, Moreno R, Cecconi M, Leaver S, De Lange DW, Boumendil A; VIP2 and COVIP study groups. Increased 30-day mortality in very old ICU patients with COVID-19 compared to patients with respiratory failure without COVID-19. Intensive Care Med. 2022 Apr;48(4):435-447. doi: 10.1007/s00134-022-06642-z. Epub 2022 Feb 26.'}, {'pmid': '34666709', 'type': 'DERIVED', 'citation': 'Bruno RR, Wernly B, Kelm M, Boumendil A, Morandi A, Andersen FH, Artigas A, Finazzi S, Cecconi M, Christensen S, Faraldi L, Lichtenauer M, Muessig JM, Marsh B, Moreno R, Oeyen S, Ohman CA, Pinto BB, Soliman IW, Szczeklik W, Valentin A, Watson X, Leaver S, Boulanger C, Walther S, Schefold JC, Joannidis M, Nalapko Y, Elhadi M, Fjolner J, Zafeiridis T, De Lange DW, Guidet B, Flaatten H, Jung C; VIP2 study group. Management and outcomes in critically ill nonagenarian versus octogenarian patients. BMC Geriatr. 2021 Oct 19;21(1):576. doi: 10.1186/s12877-021-02476-4.'}, {'pmid': '34210358', 'type': 'DERIVED', 'citation': 'Fronczek J, Polok K, de Lange DW, Jung C, Beil M, Rhodes A, Fjolner J, Gorka J, Andersen FH, Artigas A, Cecconi M, Christensen S, Joannidis M, Leaver S, Marsh B, Morandi A, Moreno R, Oeyen S, Agvald-Ohman C, Bollen Pinto B, Schefold JC, Valentin A, Walther S, Watson X, Zafeiridis T, Sviri S, van Heerden PV, Flaatten H, Guidet B, Szczeklik W; VIP1; VIP2 study group. Relationship between the Clinical Frailty Scale and short-term mortality in patients >/= 80 years old acutely admitted to the ICU: a prospective cohort study. Crit Care. 2021 Jul 1;25(1):231. doi: 10.1186/s13054-021-03632-3.'}, {'pmid': '34083342', 'type': 'DERIVED', 'citation': 'Wernly B, Beil M, Bruno RR, Binnebossel S, Kelm M, Sigal S, van Heerden PV, Boumendil A, Artigas A, Cecconi M, Marsh B, Moreno R, Oeyen S, Bollen Pinto B, Szczeklik W, Leaver S, Walther SM, Schefold JC, Joannidis M, Fjolner J, Zafeiridis T, de Lange D, Guidet B, Flaatten H, Jung C; VIP2 study group. Provision of critical care for the elderly in Europe: a retrospective comparison of national healthcare frameworks in intensive care units. BMJ Open. 2021 Jun 3;11(6):e046909. doi: 10.1136/bmjopen-2020-046909.'}, {'pmid': '33122713', 'type': 'DERIVED', 'citation': 'Wernly B, Bruno RR, Kelm M, Boumendil A, Morandi A, Andersen FH, Artigas A, Finazzi S, Cecconi M, Christensen S, Faraldi L, Lichtenauer M, Muessig JM, Marsh B, Moreno R, Oeyen S, Ohman CA, Pinto BB, Soliman IW, Szczeklik W, Niederseer D, Valentin A, Watson X, Leaver S, Boulanger C, Walther S, Schefold JC, Joannidis M, Nalapko Y, Elhadi M, Fjolner J, Zafeiridis T, De Lange DW, Guidet B, Flaatten H, Jung C. Sex-specific outcome disparities in very old patients admitted to intensive care medicine: a propensity matched analysis. Sci Rep. 2020 Oct 29;10(1):18671. doi: 10.1038/s41598-020-74910-3.'}]}, 'descriptionModule': {'briefSummary': 'The two main aims of the study:\n\n1. To investigate the relation of Frailty, Activity of daily life (ADL), Cognitive functions and Co-morbidity on survival at 30 days (and 6 months in a substudy)\n2. From the results design a prognostic score that will be validated using a subpopulation of the study cohort\n\nTwo secondary aims a\n\n1. Survival at 6 months (in a subpopulation of the study)\n2. An inter-rater validation of the Clinical Frailty Score (CFS) (in a subpopulation)\n\nSubstudies are planned with regards to the different admission categories, in particular:\n\n* trauma\n* acute respiratory failure\n* sepsis\n* combined respiratory and circulatory failure\n* medical neurological conditions In some of the substudies similar groups from the VIP1 study that uses the same admission categories (except planned admissions) will be merged.', 'detailedDescription': 'Frailty to be registered by the Clinical Frailty Scale (CFS), 1-9 point Activity of Daily life (ADL) with Katz ADL form: 0-6 points Cognition to be described by Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE) questionaire, 16 questions to be asked the care-givers Co-morbidity by listing the major comorbidity with Yes or No (Yes= 1 point) and with the number of regular drugs prescribed'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '80 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Critical ill patients admitted to the ICU ≥ 80 years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥80 admitted to an ICU as an emergency case\n\nExclusion Criteria:\n\n* elective admissions'}, 'identificationModule': {'nctId': 'NCT03370692', 'acronym': 'VIP2', 'briefTitle': 'Prognostic Score in the Very Old ICU Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Bergen'}, 'officialTitle': 'Development and Validation of a Prognostic Score in the Very Old ICU Patients (≥80 Years)', 'orgStudyIdInfo': {'id': 'VIP2'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Cognitive assesment, Frailty assessment', 'type': 'OTHER', 'description': 'Asking relatives (using a structured questionaire) about cognitive function at admission , likewise about frailty using the Clinical Frailty Score'}]}, 'contactsLocationsModule': {'locations': [{'zip': '5021', 'city': 'Bergen', 'country': 'Norway', 'facility': 'Haukeland University Hospital', 'geoPoint': {'lat': 60.39299, 'lon': 5.32415}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Bergen', 'class': 'OTHER'}, 'collaborators': [{'name': 'Helse Vest', 'class': 'OTHER'}, {'name': 'European Society of Intensive Care Medicine', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Hans Flaatten', 'investigatorAffiliation': 'University of Bergen'}}}}