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

Elderly Care Clinical Trial

— SENIOREA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01679171
• Other study ID #: PHRC-2012-01
• Secondary ID: B120579-30
• Status: Completed
• Phase: N/A
• First received: August 28, 2012
• Last updated: May 11, 2017
• Start date: September 19, 2012
• Est. completion date: July 10, 2015

Study information

• Verified date: May 2017
• Source: University Hospital, Angers
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 489
• Est. completion date: July 10, 2015
• Est. primary completion date: July 10, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 75 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Elderly Care

Locations

Country	Name	City	State
France	Intensive care unit - CHU Angers	Angers

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	One year outcome	Survival and health status will be assessed using comprehensive geriatric assessment (CGA)	1 year
Secondary	Predictors of one-year outcome	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	one year