NCT03370692

Brief Summary

The two main aims of the study:

  • 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,900

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 7, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 12, 2017

Completed
5 months until next milestone

Study Start

First participant enrolled

May 1, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
Last Updated

April 28, 2021

Status Verified

April 1, 2021

Enrollment Period

1.5 years

First QC Date

December 7, 2017

Last Update Submit

April 27, 2021

Conditions

Aged, 80 and OverCritical Care

Keywords

OutcomeSurvivalPrognostication

Outcome Measures

Primary Outcomes (1)

  • 30 days survival

    Proportion alive after 30 days

    30 days

Secondary Outcomes (3)

  • Developement of a prognostic score

    6 months

  • 6 months survival

    6 months

  • Inter-rater validation of Clinical Frailty Scale (CFS)

    At admission

Other Outcomes (1)

  • Survival analysis in pre-defined subgroups: Admission categories, use of therapeutic procedures, end-of-life desicion

    Up to 6 months

Interventions

Cognitive assesment, Frailty assessmentOTHER

Asking relatives (using a structured questionaire) about cognitive function at admission , likewise about frailty using the Clinical Frailty Score

Eligibility Criteria

Age80 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Critical ill patients admitted to the ICU ≥ 80 years

You may qualify if:

  • ≥80 admitted to an ICU as an emergency case

You may not qualify if:

  • elective admissions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Haukeland University Hospital

Bergen, 5021, Norway

Location

Related Publications (8)

  • 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.

    PMID: 38555336DERIVED

  • Mousai 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.

    PMID: 37162595DERIVED

  • 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.

    PMID: 36609257DERIVED

  • 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.

    PMID: 35218366DERIVED

  • 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.

    PMID: 34666709DERIVED

  • 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.

    PMID: 34210358DERIVED

  • 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.

    PMID: 34083342DERIVED

  • 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.

    PMID: 33122713DERIVED

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 7, 2017

First Posted

December 12, 2017

Study Start

May 1, 2018

Primary Completion

November 1, 2019

Study Completion

November 1, 2019

Last Updated

April 28, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)