Ignite Creation Date:
2025-12-24 @ 3:35 PM
Ignite Modification Date:
2026-02-21 @ 12:19 AM
Study NCT ID:
NCT03370692
Status:
COMPLETED
Last Update Posted:
2021-04-28
First Post:
2017-12-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prognostic Score in the Very Old ICU Patients
Sponsor:
University of Bergen
Organization:
Study Overview
Official Title:
Development and Validation of a Prognostic Score in the Very Old ICU Patients (≥80 Years)
Status:
COMPLETED
Status Verified Date:
2021-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VIP2
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: