The Very Old Intensive Care Patient: A Multinational Prospective Observation Study (VIP1)

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ClinicalTrials.gov Identifier: NCT03134807

Recruitment Status : Completed

First Posted : May 1, 2017

Last Update Posted : May 15, 2018

Sponsor:

Collaborator:

European Society of Intensive Care Medicine

Information provided by (Responsible Party):

Hans Flaatten, University of Bergen

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment
Critical Illness Old Age; Debility Survival	Other: Observation prospective

Detailed Description:

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.

Study Design

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Study Type :	Observational
Actual Enrollment :	5132 participants
Observational Model:	Cohort
Time Perspective:	Prospective
Official Title:	The Very Old Intensive Care Patient: A Multinational Prospective Observation Study
Actual Study Start Date :	November 1, 2016
Actual Primary Completion Date :	June 15, 2017
Actual Study Completion Date :	October 31, 2017

Groups and Cohorts

Group/Cohort	Intervention/treatment
Admission of elderly ICU patients (≥80) All consecutibve admission in 3 month period or 20 pateints	Other: Observation prospective No intervention Other Name: Observation and registration of data

Outcome Measures

Primary Outcome Measures :

Survival [ Time Frame: 30 days ]
ICU and 30 days
Frailty [ Time Frame: Pre admission ]
Clinical Frailty Scale

Eligibility Criteria

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Ages Eligible for Study:	80 Years and older (Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Critical ill elderly patients admitted to an ICU

Criteria

Inclusion Criteria:

All admissions in the group

Exclusion Criteria:

None

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03134807

Locations

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Norway
General ICU, KSK; Haukeland University Hospital
Bergen, Norway, 5021

Sponsors and Collaborators

University of Bergen

European Society of Intensive Care Medicine

Investigators

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Principal Investigator:	Hans Flaatten, Prof	University of bergen; ESICM

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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, Öhman 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, Fjølner 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.

Fronczek J, Polok K, de Lange DW, Jung C, Beil M, Rhodes A, Fjølner J, Górka J, Andersen FH, Artigas A, Cecconi M, Christensen S, Joannidis M, Leaver S, Marsh B, Morandi A, Moreno R, Oeyen S, Agvald-Öhman 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.

Wernly B, Beil M, Bruno RR, Binnebössel 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, Fjølner 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.

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, Öhman 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, Fjølner 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. Erratum in: Sci Rep. 2021 Jul 5;11(1):14184.

Jung C, Wernly B, Muessig JM, Kelm M, Boumendil A, Morandi A, Andersen FH, Artigas A, Bertolini G, Cecconi M, Christensen S, Faraldi L, Fjølner J, Lichtenauer M, Bruno RR, Marsh B, Moreno R, Oeyen S, Öhman 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: hans.flaatten@uib.no. 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.

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, Jánosi 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.

Flaatten H, De Lange DW, Morandi A, Andersen FH, Artigas A, Bertolini G, Boumendil A, Cecconi M, Christensen S, Faraldi L, Fjølner J, Jung C, Marsh B, Moreno R, Oeyen S, Öhman 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.

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Responsible Party:	Hans Flaatten, Professor and senior ICU consultant, University of Bergen
ClinicalTrials.gov Identifier:	NCT03134807
Other Study ID Numbers:	ESICM VIP1
First Posted:	May 1, 2017 Key Record Dates
Last Update Posted:	May 15, 2018
Last Verified:	May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Additional relevant MeSH terms:

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Critical Illness Frailty Disease Attributes Pathologic Processes

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