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

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ClinicalTrials.gov Identifier: NCT01679171
Recruitment Status : Completed
First Posted : September 5, 2012
Last Update Posted : May 12, 2017
Sponsor:
Information provided by (Responsible Party):

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
Elderly Care

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 : September 19, 2012
Primary Completion Date : July 10, 2015
Study Completion Date : July 10, 2015
Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. One year outcome [ Time Frame: 1 year ]
    Survival and health status will be assessed using comprehensive geriatric assessment (CGA)


Secondary Outcome Measures :
  1. Predictors of one-year outcome [ Time Frame: 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

Information from the National Library of Medicine

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Ages Eligible for Study:   75 Years and older   (Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients aged 75 and over admitted in one of the participating ICU and requiring mechanical ventilation will be recruited for this study
Criteria

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

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): NCT01679171


Locations
France
Intensive care unit - CHU Angers
Angers, France, 49933
Sponsors and Collaborators
University Hospital, Angers
Investigators
Principal Investigator: Nicolas Lerolle CHU Angers France
More Information

Responsible Party: University Hospital, Angers
ClinicalTrials.gov Identifier: NCT01679171     History of Changes
Other Study ID Numbers: PHRC-2012-01
B120579-30 ( Other Identifier: Agence Nationale de la Santé et du Médicament )
First Posted: September 5, 2012    Key Record Dates
Last Update Posted: May 12, 2017
Last Verified: May 2017

Keywords provided by University Hospital, Angers:
Elderly
Intensive care unit
Outcome
Comprehensive geriatric assessment