Elderly CareSENIOREANCT01679171
One Year Outcome of Elderly Patients Admitted to an ICU and Mechanically Ventilated
An observational study of Elderly Care, run by University Hospital, Angers at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Elderly Care
- How many people
- 489 participants
- Where
- 1 siteFrance
- Study dates
- 19 Sep 2012to 10 Jul 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- All sexes
- No healthy volunteers
- Older adult
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
Who may be able to join
- 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.
Who cannot join
- Non French-speaking person
- Failure to obtain a consent by persons authorized to do so.
- Person non-beneficiary of a social security system.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Elderly Care
- Keywords
- Elderly, Intensive care unit, Outcome, Comprehensive geriatric assessment
What is being measured
The primary outcome is the main question the study is designed to answer.
One year outcome
Survival and health status will be assessed using comprehensive geriatric assessment (CGA)
Measured: 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
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2012 (estimated)
- Study start19 Sep 2012
- Primary completion10 Jul 2015
- Study completion10 Jul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Elderly CareStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 489 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Nicolas Lerolle, Principal investigator, CHU Angers France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01679171
- Sponsor's protocol ID
- PHRC-2012-01
- Other IDs
- B120579-30
- Acronym
- SENIOREA
- Status last verified
- May 2017
- First submitted
- 28 Aug 2012
- Last updated
- 12 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
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
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- One Year Outcome of Elderly Patients Admitted to an ICU and Mechanically Ventilated
- ClinicalTrials.gov ID
- NCT01679171
- Acronym / sponsor ID
- SENIOREA / PHRC-2012-01
- Conditions
- Elderly Care
- Keywords
- Elderly, Intensive care unit, Outcome, Comprehensive geriatric assessment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 489 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 19 Sep 2012 (actual)
- Primary completion
- 10 Jul 2015 (actual)
- Study completion
- 10 Jul 2015 (actual)
- First posted
- 5 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- Non French-speaking person
- Failure to obtain a consent by persons authorized to do so.
- Person non-beneficiary of a social security system.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
One year outcome
Time frame: 1 year
Survival and health status will be assessed using comprehensive geriatric assessment (CGA)
1 secondary outcome
Predictors of one-year outcome
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2017.
- Derived from this study: PubMed 33595733Demiselle 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.
Related trials for Elderly Care
Not yet recruiting
Impact of Pharmacotherapy Optimization in Polymedicated Lebanese Older Adults in Primary Health Care Centers
Older Adults (65 Years and Older), Polypharmacy (People Under Treatment With 5 or More Drugs)
Enrolling by invitation
Promoting Aging and Thriving With HIV
HIV (Human Immunodeficiency Virus), Geriatric
Not yet recruiting
Mind Body Reprogramming Therapy for Adolescents With Chronic Fatigue
Chronic Fatigue
Recruiting
Technology-Based Intervention Pilot Testing
Dementia, Elder Abuse
RecruitingObservational study
Predictive Model for Mortality in Older People With Critical Illness
Critical Illness
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicolas Lerolle principal investigator
CHU Angers France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Elderly Care, run by University Hospital, Angers at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
One year outcome (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01679171, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2017.