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Completed

NCT Number: NCT03370692

Prognostic Score in the Very Old ICU Patients

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.

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Key information

Conditions

Aged, 80 and Over Critical Care

Age range

80 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Haukeland University Hospital

Bergen, 5021, Norway

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ≥80 admitted to an ICU as an emergency case

Exclusion criteria

  • elective admissions

Treatment and study plan

Cognitive assesment, Frailty assessment

Other

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

Primary outcomes

  1. 30 days survival

    Time frame: 30 days

    Proportion alive after 30 days

Secondary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Bergen

Other

Collaborators

  • European Society of Intensive Care Medicine
  • Helse Vest

Registry information

Official study title

Development and Validation of a Prognostic Score in the Very Old ICU Patients (≥80 Years)

Acronym: VIP2

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 12, 2017
Registry last updated
Apr 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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