Aged, 80 and OverVIP2NCT03370692
Prognostic Score in the Very Old ICU Patients
An observational study of Aged, 80 and Over and Critical Care, run by University of Bergen at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 80 years and older
- Conditions the study is for
- Aged, 80 and Over, Critical Care
- What is being tested?
- Cognitive assesment, Frailty assessment
- How many people
- 3,900 participants
- Where
- 1 siteNorway
- Study dates
- 1 May 2018to 1 Nov 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 80 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Critical ill patients admitted to the ICU ≥ 80 years
Who may be able to join
- ≥80 admitted to an ICU as an emergency case
Who cannot join
- elective admissions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development and Validation of a Prognostic Score in the Very Old ICU Patients (≥80 Years)
The two main aims of the study:
- 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)
- From the results design a prognostic score that will be validated using a subpopulation of the study cohort
Read more
Two secondary aims a
- Survival at 6 months (in a subpopulation of the study)
- 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.
Read the 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
- Conditions
- Aged, 80 and Over, Critical Care
- Being tested
- Cognitive assesment, Frailty assessment
- Keywords
- Outcome, Survival, Prognostication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive assesment, Frailty assessmentOther
Asking relatives (using a structured questionaire) about cognitive function at admission , likewise about frailty using the Clinical Frailty Score
What is being measured
The primary outcome is the main question the study is designed to answer.
30 days survival
Proportion alive after 30 days
Measured: 30 days
Secondary outcomes (3)
Developement of a prognostic score
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.
Measured: 6 months
6 months survival
Proportion alive after 6 months
Measured: 6 months
Inter-rater validation of Clinical Frailty Scale (CFS)
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.
Measured: At admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2017
- Study start1 May 2018
- Primary completion1 Nov 2019
- Study completion1 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Aged, 80 and OverStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,900 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bergen
- Sponsor type
- University, hospital or other
- Collaborators
- Helse Vest, European Society of Intensive Care Medicine
- Responsible party
- Principal investigator, Hans Flaatten, University of Bergen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03370692
- Sponsor's protocol ID
- VIP2
- Acronym
- VIP2
- Status last verified
- Apr 2021
- First submitted
- 7 Dec 2017
- Last updated
- 28 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38555336Mousai 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.
PubMed 37162595Beil 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.
PubMed 36609257Guidet 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.
PubMed 35218366Bruno 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.
PubMed 34666709Fronczek 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.
PubMed 34210358Wernly 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.
PubMed 34083342Wernly 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.
PubMed 33122713
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of a Prognostic Score in the Very Old ICU Patients (≥80 Years)
- ClinicalTrials.gov ID
- NCT03370692
- Acronym / sponsor ID
- VIP2 / VIP2
- Conditions
- Aged, 80 and Over, Critical Care
- Keywords
- Outcome, Survival, Prognostication
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,900 participants (actual)
- Lead sponsor
- University of BergenUniversity, hospital or other
- Collaborators
- Helse Vest, European Society of Intensive Care Medicine
- Study start
- 1 May 2018 (actual)
- Primary completion
- 1 Nov 2019 (actual)
- Study completion
- 1 Nov 2019 (actual)
- First posted
- 12 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The two main aims of the study:
- 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)
- From the results design a prognostic score that will be validated using a subpopulation of the study cohort
Two secondary aims a
- Survival at 6 months (in a subpopulation of the study)
- 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
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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 80 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Critical ill patients admitted to the ICU ≥ 80 years
Key inclusion criteria (1 listed)
- ≥80 admitted to an ICU as an emergency case
Key exclusion criteria (1 listed)
- elective admissions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive assesment, Frailty assessmentAsking relatives (using a structured questionaire) about cognitive function at admission , likewise about frailty using the Clinical Frailty Score | Other | – |
Primary outcome
30 days survival
Time frame: 30 days
Proportion alive after 30 days
3 secondary outcomes
Developement of a prognostic score
Time frame: 6 months
6 months survival
Time frame: 6 months
Inter-rater validation of Clinical Frailty Scale (CFS)
Time frame: At admission
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2021.
- Derived from this study: PubMed 38555336de 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.
- Derived from this study: PubMed 37162595Mousai 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.
- Derived from this study: PubMed 36609257Beil 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.
- Derived from this study: PubMed 35218366Guidet 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.
- Derived from this study: PubMed 34666709Bruno 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.
- Derived from this study: PubMed 34210358Fronczek 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.
- Derived from this study: PubMed 34083342Wernly 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.
- Derived from this study: PubMed 33122713Wernly 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.
- Individual participant dataSharing planned: No
Related trials for Aged, 80 and Over
Active, not recruiting
Reducing Falls With Progressive Resistance Training for the Oldest Old Adults With Reduced Muscle Strength
Sarcopenia, Aging
Not yet recruitingObservational study
Regulation of Platelet Function in Older Patients With Atrial Fibrillation
Atrial Fibrillation, Thrombotic Risk
Active, not recruitingObservational study
Vanderbilt Memory and Aging Project
Alzheimer Disease, Aging
RecruitingObservational study
Risks and Benefits of Radiofrequency Ablation for Chronic Venous Insufficiency (CEAP C3-C6) in Patients Aged 80 and Over
Chronic Venous Insufficiency, CVI, Radiofrequency Ablation
Not yet recruiting
Neuromuscular Electrical Stimulation in Critically Ill Patients Aged 80 and Over
Intensive Care Units (ICUs), Muscle Atrophy or Weakness
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aged, 80 and Over and Critical Care, run by University of Bergen at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30 days survival (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03370692, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2021.