NCT01679171

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
489

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 28, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 5, 2012

Completed
14 days until next milestone

Study Start

First participant enrolled

September 19, 2012

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2015

Completed
Last Updated

May 12, 2017

Status Verified

May 1, 2017

Enrollment Period

2.8 years

First QC Date

August 28, 2012

Last Update Submit

May 11, 2017

Conditions

Keywords

ElderlyIntensive care unitOutcomeComprehensive geriatric assessment

Outcome Measures

Primary Outcomes (1)

  • One year outcome

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

    1 year

Secondary Outcomes (1)

  • Predictors of one-year outcome

    one year

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Intensive care unit - CHU Angers

Angers, 49933, France

Location

Related Publications (1)

  • Demiselle J, Duval G, Hamel JF, Renault A, Bodet-Contentin L, Martin-Lefevre L, Vivier D, Villers D, Lefevre M, Robert R, Markowicz P, Lavoue S, Courte A, Lebas E, Chevalier S, Annweiler C, Lerolle N. Determinants of hospital and one-year mortality among older patients admitted to intensive care units: results from the multicentric SENIOREA cohort. Ann Intensive Care. 2021 Feb 17;11(1):35. doi: 10.1186/s13613-021-00804-w.

Study Officials

  • Nicolas Lerolle

    CHU Angers France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 28, 2012

First Posted

September 5, 2012

Study Start

September 19, 2012

Primary Completion

July 10, 2015

Study Completion

July 10, 2015

Last Updated

May 12, 2017

Record last verified: 2017-05

Locations