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Clinical Trials/NCT03370692
NCT03370692
Completed
N/A

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

University of Bergen1 site in 1 country3,900 target enrollmentMay 1, 2018
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ConditionsAged, 80 and OverCritical Care

Overview

Phase
N/A
Intervention
Not specified
Conditions
Aged, 80 and Over
Sponsor
University of Bergen
Enrollment
3900
Locations
1
Primary Endpoint
30 days survival
Status
Completed
Last Updated
5 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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

Registry
clinicaltrials.gov
Start Date
May 1, 2018
End Date
November 1, 2019
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Hans Flaatten

Professor

University of Bergen

Eligibility Criteria

Inclusion Criteria

  • •≥80 admitted to an ICU as an emergency case

Exclusion Criteria

  • •elective admissions

Outcomes

Primary Outcomes

30 days survival

Time Frame: 30 days

Proportion alive after 30 days

Secondary Outcomes

  • 6 months survival(6 months)
  • Developement of a prognostic score(6 months)
  • Inter-rater validation of Clinical Frailty Scale (CFS)(At admission)

Study Sites (1)

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