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CompletedNCT01679171SENIOREAUpdated May 12, 2017

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

An observational study in Elderly Care, sponsored by University Hospital, Angers. Completed at 1 site in France. Open to participants aged 75 Years and older. Per ClinicalTrials.gov, last updated 2017-05-12.

Sponsored by University Hospital, Angers · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
489
Ages
75 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Elderly Care

Keywords

  • Elderly
  • Intensive care unit
  • Outcome
  • Comprehensive geriatric assessment
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In context

Lead sponsor

University Hospital, Angers is the lead sponsor of 464 studies on the registry; 116 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
75 Years and older
Sexes eligible
All
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

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

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.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
489 participants (actual)
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What researchers measure

Primary outcomes

  1. One year outcome

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

    Time frame: 1 year

Secondary outcomes

  1. 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

    Time frame: one year

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Study locations

1 site
  • Intensive care unit - CHU Angers
    Angers, 49933, France
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References and documents

Publications

  • 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. PubMed 33595733 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 12, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01679171
Lead sponsor
University Hospital, Angers
Responsible party
Sponsor
First posted
Sep 5, 2012
Start date
Sep 19, 2012
Primary completion
Jul 10, 2015
Completion
Jul 10, 2015
Last update
May 12, 2017

Study contacts

Nicolas Lerolle
principal investigator · CHU Angers France

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.

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