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

Completed

• Conditions: Elderly Care

• Registration Number: NCT01679171
• Lead Sponsor: University Hospital, Angers

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-08-28
• Study First Submitted QC: 2012-08-30
• Study First Posted: 2012-09-05
• Study Start: 2012-09-19
• Primary Completion: 2015-07-10
• Study Completion: 2015-07-10
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-11
• Last Update Posted: 2017-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 489

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
One year outcome	1 year	Survival and health status will be assessed using comprehensive geriatric assessment (CGA)

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Intensive care unit - CHU Angers; 🇫🇷 Angers, France