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SENIOREA: One Year Outcome of Elderly Patients Admitted to an ICU and Mechanically Ventilated

Sponsor
University Hospital, Angers (Other)
Overall Status
Completed
CT.gov ID
NCT01679171
Collaborator
(none)
489
Enrollment
1
Location
33.6
Actual Duration (Months)
14.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Elderly patients are increasingly admitted in the Intensive Care Unit. Short-term outcome (e.g. hospital survival) of an ICU stay is improving in this population but little data have been published on long-term outcome. Beyond survival, outcome assessment in the elderly requires to evaluate several aspects of health: mental status, activity of daily living, pain, depression, frailty… referred by geriatrician as "comprehensive geriatric assessment' (CGA).

The purpose of the SENIOREA study is to evaluate one year outcome of elderly patients mechanically ventilated in the ICU by performing CGA one year after ICU admission. CGA will be performed on the patients' site of living.

This prospective multicentric trial will be conducted over 8 medico-surgical ICUs.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    489 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    One Year Outcome of Elderly Patients Admitted to an ICU and Mechanically Ventilated
    Actual Study Start Date :
    Sep 19, 2012
    Actual Primary Completion Date :
    Jul 10, 2015
    Actual Study Completion Date :
    Jul 10, 2015

    Outcome Measures

    Primary Outcome Measures

    1. One year outcome [1 year]

      Survival and health status will be assessed using comprehensive geriatric assessment (CGA)

    Secondary Outcome Measures

    1. Predictors of one-year outcome [one year]

      The secondary assessment criteria as predictors of one year outcome will be researched among: CGA on ICU entry (based on family interview) Vitamin D blood concentration on ICU entry SOFA and SAPSII score on ICU entry Duration of organ dysfunction (ventilator support, renal replacement therapy, vasopressor) ICU length of stay

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    75 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Patients aged 75 or over

    2. Admitted in a participating ICU

    3. Requiring mechanical ventilation (invasive or non invasive), initiated before ICU admission or during the 48 first hours after admission.

    Exclusion Criteria:

    1. Non French-speaking person

    2. Failure to obtain a consent by persons authorized to do so.

    3. Person non-beneficiary of a social security system.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Intensive care unit - CHU Angers Angers France 49933

    Sponsors and Collaborators

    • University Hospital, Angers

    Investigators

    • Principal Investigator: Nicolas Lerolle, CHU Angers France

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Angers
    ClinicalTrials.gov Identifier:
    NCT01679171
    Other Study ID Numbers:
    • PHRC-2012-01
    • B120579-30
    First Posted:
    Sep 5, 2012
    Last Update Posted:
    May 12, 2017
    Last Verified:
    May 1, 2017
    Keywords provided by University Hospital, Angers
    Elderly
    Intensive care unit
    Outcome
    Comprehensive geriatric assessment

    Study Results

    No Results Posted as of May 12, 2017