Prognostic Score in the Very Old ICU Patients

Completed

• Conditions: Critical Care; Aged, 80 and Over

• Registration Number: NCT03370692
• Lead Sponsor: University of Bergen

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

Study Timeline

• Study First Submitted: 2017-12-07
• Study First Submitted QC: 2017-12-07
• Study First Posted: 2017-12-12
• Study Start: 2018-05-01
• Primary Completion: 2019-11-01
• Study Completion: 2019-11-01
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-27
• Last Update Posted: 2021-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3900

Inclusion Criteria

• ≥80 admitted to an ICU as an emergency case

Exclusion Criteria

• elective admissions

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
30 days survival	30 days	Proportion alive after 30 days

Secondary Outcome Measures

Name	Time	Method
6 months survival	6 months	Proportion alive after 6 months
Developement of a prognostic score	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.
Inter-rater validation of Clinical Frailty Scale (CFS)	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.

Trial Locations

Locations (1)

Haukeland University Hospital; 🇳🇴 Bergen, Norway