Prognostic Score in the Very Old ICU Patients

Critical Care Clinical Trial

— VIP2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03370692
• Other study ID #: VIP2
• Status: Completed
• Start date: May 1, 2018
• Est. completion date: November 1, 2019

Study information

• Verified date: April 2021
• Source: University of Bergen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3900
• Est. completion date: November 1, 2019
• Est. primary completion date: November 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 80 Years and older

Eligibility

Inclusion Criteria:

• =80 admitted to an ICU as an emergency case

Exclusion Criteria:

• elective admissions

Related Conditions & MeSH terms

• Aged, 80 and Over
• Critical Care

Intervention

Other:
• Cognitive assesment, Frailty assessment
Asking relatives (using a structured questionaire) about cognitive function at admission , likewise about frailty using the Clinical Frailty Score

Locations

Country	Name	City	State
Norway	Haukeland University Hospital	Bergen

Sponsors (3)

Lead Sponsor	Collaborator
University of Bergen	European Society of Intensive Care Medicine, Helse Vest

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Survival analysis in pre-defined subgroups: Admission categories, use of therapeutic procedures, end-of-life desicion	Proportions alive after 30 days and 6 months	Up to 6 months
Primary	30 days survival	Proportion alive after 30 days	30 days
Secondary	Developement of a prognostic score	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.	6 months
Secondary	6 months survival	Proportion alive after 6 months	6 months
Secondary	Inter-rater validation of Clinical Frailty Scale (CFS)	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.	At admission