Prognostic Score in the Very Old ICU Patients (VIP2)

• ClinicalTrials.gov Identifier: NCT03370692
• Recruitment Status: Completed
• First Posted: December 12, 2017
• Last Update Posted: April 28, 2021
• Sponsor: University of Bergen
• Collaborators: Helse Vest; European Society of Intensive Care Medicine
• Information provided by (Responsible Party): Hans Flaatten, University of Bergen

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment
Aged, 80 and Over; Critical Care	Other: Cognitive assesment, Frailty assessment

Detailed Description:

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

Study Design

• Study Type: Observational
• Actual Enrollment: 3900 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Development and Validation of a Prognostic Score in the Very Old ICU Patients (≥80 Years)
• Actual Study Start Date: May 1, 2018
• Actual Primary Completion Date: November 1, 2019
• Actual Study Completion Date: November 1, 2019

Groups and Cohorts

Intervention Details:

• Other: Cognitive assesment, Frailty assessment
  Asking relatives (using a structured questionaire) about cognitive function at admission , likewise about frailty using the Clinical Frailty Score

Outcome Measures

Primary Outcome Measures :

1. 30 days survival [ Time Frame: 30 days ]
   Proportion alive after 30 days

Secondary Outcome Measures :

1. Developement of a prognostic score [ Time Frame: 6 months ]
   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.
2. 6 months survival [ Time Frame: 6 months ]
   Proportion alive after 6 months
3. Inter-rater validation of Clinical Frailty Scale (CFS) [ Time Frame: At admission ]
   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.

Other Outcome Measures:

1. Survival analysis in pre-defined subgroups: Admission categories, use of therapeutic procedures, end-of-life desicion [ Time Frame: Up to 6 months ]
   Proportions alive after 30 days and 6 months

Eligibility Criteria

• 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 patients admitted to the ICU ≥ 80 years

Criteria

Inclusion Criteria:

• ≥80 admitted to an ICU as an emergency case

Exclusion Criteria:

• elective admissions

Contacts and Locations

Locations

Norway

Haukeland University Hospital

Bergen, Norway, 5021

Sponsors and Collaborators

University of Bergen

Helse Vest

European Society of Intensive Care Medicine

More Information

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

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. Erratum In: Intensive Care Med. 2022 Mar 31;:

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.

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.

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.

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. Erratum In: Sci Rep. 2021 Jul 5;11(1):14184.

• Responsible Party: Hans Flaatten, Professor, University of Bergen
• ClinicalTrials.gov Identifier: NCT03370692
• Other Study ID Numbers: VIP2
• First Posted: December 12, 2017
• Last Update Posted: April 28, 2021
• Last Verified: April 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

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

Keywords provided by Hans Flaatten, University of Bergen:

Outcome; Survival; Prognostication