The Very Old Intensive Care Patient: A Multinational Prospective Observation Study

NCT ID: NCT03134807

Last Updated: 2018-05-15

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

5132 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-11-01

Study Completion Date

2017-10-31

Brief Summary

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* The primary aim is to document the incidence and short-term outcome of the elderly ICU patient (≥ 80 years) using a multicentre, multi national approach
* The secondary aim is to investigate the properties of a simple frailty index in this cohort, and in particular if this is an instrument that can be used in resource and outcome prediction in this group
* To create hypothesis for further studies, in particular on various outcome prediction

Detailed Description

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The investigators have chosen to use a prospective registration of routinely collected data in this ICU population. The study is mainly European based, but will also allow for ICUs outside Europe to participate.

20 consecutive ICU admission in patients ≥ 80 years of age will be collected OR all patients ≥ 80 years in a three months' period (whatever comes first).

Data are collected electronically through an e-CRF and with baseline documentation of the ICU. The database is located in Denmark, at the Department of Epidemiology, University of Aarhus (http://vip1study.com/) . Each ICU will only have access through the database of their own patients, and patient ID is not registered (Names, birth-date or social security numbers) so it is in that sense anonymous.

Even with de-identified data, most countries must seek necessary consent from the authorities to collect such data, and hence there will be a period between ICU recruitment (starting April 2016) and patient recruitment (October 1. 2016) to allow for this to be done prior to study start.

The goal is to recruit at least 100 ICUs which will give data from approximately 2000 elderly patients.

Conditions

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Critical Illness Old Age; Debility Survival

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Admission of elderly ICU patients (≥80)

All consecutibve admission in 3 month period or 20 pateints

Observation prospective

Intervention Type OTHER

No intervention

Interventions

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Observation prospective

No intervention

Intervention Type OTHER

Other Intervention Names

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Observation and registration of data

Eligibility Criteria

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Inclusion Criteria

* All admissions in the group

Exclusion Criteria

* None
Minimum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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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 and senior ICU consultant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hans Flaatten, Prof

Role: PRINCIPAL_INVESTIGATOR

University of bergen; ESICM

Locations

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General ICU, KSK; Haukeland University Hospital

Bergen, , Norway

Site Status

Countries

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Norway

References

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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)

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)

Jung C, Wernly B, Muessig JM, Kelm M, Boumendil A, Morandi A, Andersen FH, Artigas A, Bertolini G, Cecconi M, Christensen S, Faraldi L, Fjolner J, Lichtenauer M, Bruno RR, Marsh B, Moreno R, Oeyen S, Ohman CA, Pinto BB, Soliman IW, Szczeklik W, Valentin A, Watson X, Zafeiridis T, De Lange DW, Guidet B, Flaatten H; VIP1 study group. Electronic address: [email protected]. A comparison of very old patients admitted to intensive care unit after acute versus elective surgery or intervention. J Crit Care. 2019 Aug;52:141-148. doi: 10.1016/j.jcrc.2019.04.020. Epub 2019 May 2.

Reference Type DERIVED
PMID: 31055187 (View on PubMed)

Muessig JM, Nia AM, Masyuk M, Lauten A, Sacher AL, Brenner T, Franz M, Bloos F, Ebelt H, Schaller SJ, Fuest K, Rabe C, Dieck T, Steiner S, Graf T, Janosi RA, Meybohm P, Simon P, Utzolino S, Rahmel T, Barth E, Schuster M, Kelm M, Jung C. Clinical Frailty Scale (CFS) reliably stratifies octogenarians in German ICUs: a multicentre prospective cohort study. BMC Geriatr. 2018 Jul 13;18(1):162. doi: 10.1186/s12877-018-0847-7.

Reference Type DERIVED
PMID: 30005622 (View on PubMed)

Flaatten H, De Lange DW, Morandi A, Andersen FH, Artigas A, Bertolini G, Boumendil A, Cecconi M, Christensen S, Faraldi L, Fjolner J, Jung C, Marsh B, Moreno R, Oeyen S, Ohman CA, Pinto BB, Soliman IW, Szczeklik W, Valentin A, Watson X, Zaferidis T, Guidet B; VIP1 study group. The impact of frailty on ICU and 30-day mortality and the level of care in very elderly patients (>/= 80 years). Intensive Care Med. 2017 Dec;43(12):1820-1828. doi: 10.1007/s00134-017-4940-8. Epub 2017 Sep 21.

Reference Type DERIVED
PMID: 28936626 (View on PubMed)

Other Identifiers

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ESICM VIP1

Identifier Type: -

Identifier Source: org_study_id

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