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Prognostic Score in the Very Old ICU Patients

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03370692
Acronym
VIP2
Enrollment
3900
Registered
2017-12-12
Start date
2018-05-01
Completion date
2019-11-01
Last updated
2021-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aged, 80 and Over, Critical Care

Keywords

Outcome, Survival, Prognostication

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.

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

Interventions

OTHERCognitive assesment, Frailty assessment

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

Sponsors

Helse Vest
CollaboratorOTHER
European Society of Intensive Care Medicine
CollaboratorOTHER
University of Bergen
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
80 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* ≥80 admitted to an ICU as an emergency case

Exclusion criteria

* elective admissions

Design outcomes

Primary

MeasureTime frameDescription
30 days survival30 daysProportion alive after 30 days

Secondary

MeasureTime frameDescription
Developement of a prognostic score6 monthsDevelopement 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.
6 months survival6 monthsProportion alive after 6 months
Inter-rater validation of Clinical Frailty Scale (CFS)At admissionThe 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

MeasureTime frameDescription
Survival analysis in pre-defined subgroups: Admission categories, use of therapeutic procedures, end-of-life desicionUp to 6 monthsProportions alive after 30 days and 6 months

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026