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OpenTrials
Completed

NCT Number: NCT01679171

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

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.

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Key information

Conditions

Elderly Care

Age range

75 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Intensive care unit - CHU Angers

Angers, 49933, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients aged 75 or over
  • Admitted in a participating ICU
  • Requiring mechanical ventilation (invasive or non invasive), initiated before ICU admission or during the 48 first hours after admission.

Exclusion criteria

  • Non French-speaking person
  • Failure to obtain a consent by persons authorized to do so.
  • Person non-beneficiary of a social security system.

Treatment and study plan

Primary outcomes

  1. One year outcome

    Time frame: 1 year

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

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Angers

Other Gov

Registry information

Acronym: SENIOREA

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Sep 5, 2012
Registry last updated
May 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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