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

• ClinicalTrials.gov Identifier: NCT01679171
• Recruitment Status: Completed
• First Posted: September 5, 2012
• Last Update Posted: May 12, 2017
• Sponsor: University Hospital, Angers
• Information provided by (Responsible Party): University Hospital, Angers

Tracking Information

• First Submitted Date: August 28, 2012
• First Posted Date: September 5, 2012
• Last Update Posted Date: May 12, 2017
• Actual Study Start Date: September 19, 2012
• Actual Primary Completion Date: July 10, 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 30, 2012)

One year outcome [ Time Frame: 1 year ]

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: August 30, 2012)

Predictors of one-year outcome [ Time Frame: one year ]

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: One Year Outcome of Elderly Patients Admitted to an ICU and Mechanically Ventilated
• Official Title: One Year Outcome of Elderly Patients Admitted to an ICU and Mechanically Ventilated

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.

• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• 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
• Condition: Elderly Care
• Intervention: Not Provided
• Study Groups/Cohorts: Not Provided
• Publications *: Demiselle J, Duval G, Hamel JF, Renault A, Bodet-Contentin L, Martin-Lefèvre L, Vivier D, Villers D, Lefèvre M, Robert R, Markowicz P, Lavoué 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 11, 2017): 489
• Original Estimated Enrollment (submitted: August 30, 2012): 500
• Actual Study Completion Date: July 10, 2015
• Actual Primary Completion Date: July 10, 2015 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 75 Years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France

Administrative Information

• NCT Number: NCT01679171
• Other Study ID Numbers: PHRC-2012-01; B120579-30 ( Other Identifier: Agence Nationale de la Santé et du Médicament )
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: University Hospital, Angers
• Study Sponsor: University Hospital, Angers
• Collaborators: Not Provided

Investigators

• Principal Investigator: Nicolas Lerolle; CHU Angers France

• PRS Account: University Hospital, Angers
• Verification Date: May 2017