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Prognostic Score in the Very Old ICU Patients (VIP2)

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ClinicalTrials.gov Identifier: NCT03370692
Recruitment Status : Recruiting
First Posted : December 12, 2017
Last Update Posted : May 17, 2018
Sponsor:
Collaborators:
Helse Vest
European Society of Intensive Care Medicine
Information provided by (Responsible Party):
Hans Flaatten, 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)

Condition or disease Intervention/treatment
Aged, 80 and Over Critical Care Other: Cognitive assesment, Frailty assessment

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)

Study Type : Observational
Estimated Enrollment : 5000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Development and Validation of a Prognostic Score in the Very Old ICU Patients (≥80 Years)
Actual Study Start Date : May 1, 2018
Estimated Primary Completion Date : May 1, 2019
Estimated Study Completion Date : November 1, 2019

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


Primary Outcome Measures :
  1. 30 days survival [ Time Frame: 30 days ]
    Proportion alive after 30 days


Secondary Outcome Measures :
  1. Developement of a prognostic score [ Time Frame: 3 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.



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Ages Eligible for Study:   80 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Critical ill patients admitted to the ICU ≥ 80 years
Criteria

Inclusion Criteria:

  • ≥80 admitted to an ICU as an emergency case

Exclusion Criteria:

  • elective admissions

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03370692


Contacts
Contact: Hans Flaatten, MD 0047 46422169 hans.flaatten@uib.no

Locations
Norway
Haukeland University Hospital Recruiting
Bergen, Norway, 5021
Contact: Brit Sjoboe       brit.agot.sjobo@helse-bergen.no   
Sponsors and Collaborators
University of Bergen
Helse Vest
European Society of Intensive Care Medicine

Responsible Party: Hans Flaatten, Professor, University of Bergen
ClinicalTrials.gov Identifier: NCT03370692     History of Changes
Other Study ID Numbers: VIP2
First Posted: December 12, 2017    Key Record Dates
Last Update Posted: May 17, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hans Flaatten, University of Bergen:
Outcome
Survival
Prognostication