Critical IllnessVIP1NCT03134807
The Very Old Intensive Care Patient: A Multinational Prospective Observation Study
An observational study of Critical Illness and Old Age; Debility, run by University of Bergen at 1 site in Norway.
Trial 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… Read more about this study
- Who is it for?
- Ages 80 years and older
- Conditions the study is for
- Critical Illness, Old Age; Debility, Survival
- What is being tested?
- Observation prospective
- How many people
- 5,132 participants
- Where
- 1 siteNorway
- Study dates
- 1 Nov 2016to 31 Oct 2017
- 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 elderly patients admitted to an ICU
Who may be able to join
- All admissions in the group
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
- 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
Read the 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.
- Conditions
- Critical Illness, Old Age; Debility, Survival
- Being tested
- Observation prospective
- Medical subject headings
- Critical Illness, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observation prospectiveOther
Also called Observation and registration of data
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Admission of elderly ICU patients (≥80) | All consecutibve admission in 3 month period or 20 pateints Receives: Other: Observation prospective |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
ICU and 30 days
Measured: 30 days
Frailty
Clinical Frailty Scale
Measured: Pre admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2017
- Study start1 Nov 2016
- Primary completion15 Jun 2017
- Study completion31 Oct 2017
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 Critical IllnessStudies 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
- 5,132 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bergen
- Sponsor type
- University, hospital or other
- Collaborators
- European Society of Intensive Care Medicine
- Responsible party
- Principal investigator, Hans Flaatten, University of Bergen
- Investigators
- Hans Flaatten, Prof, Principal investigator, University of bergen; ESICM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03134807
- Sponsor's protocol ID
- ESICM VIP1
- Acronym
- VIP1
- Status last verified
- May 2018
- First submitted
- 26 Apr 2017
- Last updated
- 15 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36609257Bruno 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 33122713Jung 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: 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.
PubMed 31055187Muessig 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.
PubMed 30005622Flaatten 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.
PubMed 28936626
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Very Old Intensive Care Patient: A Multinational Prospective Observation Study
- ClinicalTrials.gov ID
- NCT03134807
- Acronym / sponsor ID
- VIP1 / ESICM VIP1
- Conditions
- Critical Illness, Old Age; Debility, Survival
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,132 participants (actual)
- Lead sponsor
- University of BergenUniversity, hospital or other
- Collaborators
- European Society of Intensive Care Medicine
- Study start
- 1 Nov 2016 (actual)
- Primary completion
- 15 Jun 2017 (actual)
- Study completion
- 31 Oct 2017 (actual)
- First posted
- 1 May 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 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
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Admission of elderly ICU patients (≥80) | – | Other: Observation prospectiveAll consecutibve admission in 3 month period or 20 pateints |
Who may qualify
- Ages
- 80 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Critical ill elderly patients admitted to an ICU
Key inclusion criteria (1 listed)
- All admissions in the group
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Observation prospectiveAlso: Observation and registration of dataNo intervention | Other | Admission of elderly ICU patients (≥80) |
Primary outcome
Survival
Time frame: 30 days
ICU and 30 days
Frailty
Time frame: Pre admission
Clinical Frailty Scale
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 15 May 2018.
- 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 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.
- Derived from this study: PubMed 31055187Jung 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: 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.
- Derived from this study: PubMed 30005622Muessig 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.
- Derived from this study: PubMed 28936626Flaatten 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.
- Individual participant dataSharing planned: No
Related trials for Critical Illness
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Recruiting
Development and Preliminary Validation of Intelligent Video Laryngoscope for Emergency Use
Critically Ill Patients Requiring Mechanical Ventilation
Active, not recruiting
Weighted Blankets for Agitation in Adults in the Intensive Care Unit
Psychomotor Agitation, Critical Illness
Not yet recruitingObservational study
Core Competencies in General Intensive Care Ultrasound (GenIUS): a Delphi Study
Critical Illness, Ultrasound
RecruitingObservational study
Predicting Extubation Failure Using Machine Learning
Extubation Failure, Critical Illness
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.
Hans Flaatten, Prof principal investigator
University of bergen; ESICM
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 Critical Illness and Old Age; Debility, 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 15 May 2018. 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?
Survival (time frame: 30 days). The study lists 2 primary outcomes in all. 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 NCT03134807, 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 15 May 2018.