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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by University Hospital, Angers
Sponsor:
Information provided by (Responsible Party):
University Hospital, Angers
ClinicalTrials.gov Identifier:
NCT01679171
First received: August 28, 2012
Last updated: February 28, 2013
Last verified: February 2013
  Purpose

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
Elderly Care

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: One Year Outcome of Elderly Patients Admitted to an ICU and Mechanically Ventilated

Further study details as provided by University Hospital, Angers:

Primary Outcome Measures:
  • One year outcome [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Survival and health status will be assessed using comprehensive geriatric assessment (CGA)


Secondary Outcome Measures:
  • Predictors of one-year outcome [ Time Frame: one year ] [ Designated as safety issue: No ]

    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


Estimated Enrollment: 500
Study Start Date: September 2012
  Eligibility

Ages Eligible for Study:   75 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01679171

Contacts
Contact: Nicolas Lerolle, MD, PhD nicolas.lerolle@univ-angers.fr

Locations
France
Intensive care unit - CHU Angers Recruiting
Angers, France, 49933
Contact: Lerolle Nicolas       nilerolle@chu-angers.fr   
Sponsors and Collaborators
University Hospital, Angers
Investigators
Principal Investigator: Nicolas Lerolle CHU Angers France
  More Information

No publications provided

Responsible Party: University Hospital, Angers
ClinicalTrials.gov Identifier: NCT01679171     History of Changes
Other Study ID Numbers: PHRC-2012-01, B120579-30
Study First Received: August 28, 2012
Last Updated: February 28, 2013
Health Authority: France: Ministry of Health

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

ClinicalTrials.gov processed this record on October 28, 2014