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

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ClinicalTrials.gov Identifier: NCT01679171
Recruitment Status : Completed
First Posted : September 5, 2012
Last Update Posted : May 12, 2017
Sponsor:
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
Change History
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
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
Removed Location Countries  
 
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