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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01679171

Acronym

SENIOREA

Enrollment

489

Registered

2012-09-05

Start date

2012-09-19

Completion date

2015-07-10

Last updated

2017-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Elderly Care

Keywords

Elderly, Intensive care unit, Outcome, Comprehensive geriatric assessment

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

75 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
One year outcome	1 year	Survival and health status will be assessed using comprehensive geriatric assessment (CGA)

Secondary

Measure	Time frame	Description
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

Countries

France

Outcome results