Prognostic Score in the Very Old ICU Patients

NCT ID: NCT03370692

Last Updated: 2021-04-28

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

3900 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-05-01

Study Completion Date

2019-11-01

Brief Summary

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The two main aims of the study:

1. 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)
2. From the results design a prognostic score that will be validated using a subpopulation of the study cohort

Two secondary aims a

1. Survival at 6 months (in a subpopulation of the study)
2. An inter-rater validation of the Clinical Frailty Score (CFS) (in a subpopulation)

Substudies are planned with regards to the different admission categories, in particular:

* trauma
* acute respiratory failure
* sepsis
* combined respiratory and circulatory failure
* 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.

Detailed Description

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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

Conditions

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Aged, 80 and Over Critical Care

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Cognitive assesment, Frailty assessment

Asking relatives (using a structured questionaire) about cognitive function at admission , likewise about frailty using the Clinical Frailty Score

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* ≥80 admitted to an ICU as an emergency case

Exclusion Criteria

* elective admissions
Minimum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Helse Vest

OTHER

Sponsor Role collaborator

European Society of Intensive Care Medicine

OTHER

Sponsor Role collaborator

University of Bergen

OTHER

Sponsor Role lead

Responsible Party

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Hans Flaatten

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Haukeland University Hospital

Bergen, , Norway

Site Status

Countries

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Norway

References

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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.

Reference Type DERIVED
PMID: 38555336 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37162595 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36609257 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35218366 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34666709 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34210358 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34083342 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33122713 (View on PubMed)

Other Identifiers

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VIP2

Identifier Type: -

Identifier Source: org_study_id

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