Quality of Life Clinical Trial
Official title:
Anesthesia Geriatric Evaluation and the Prediction of Quality of Life in Elderly Cardiac Surgery Patients
A prospective observational cohort study to assess the predictive value of preoperative frailty on postoperative quality of life in cardiac surgery patients.
Introduction:
The current population is ageing in a rapid pace. Currently elderly represent 17.8% of the
Dutch population. Most recent estimates show this will increase to 25.6% 20 years' time. This
rise in elderly will also reflect on the population of patients being referred for cardiac
surgery. Especially elderly patients are at risk for postoperative complications, mortality
or functional decline. In frail elderly this effect might be more pronounced. Frailty is an
umbrella term that encompasses patient related factors such as weight loss, muscle wasting,
inactivity, comorbidities and polypharmacy. Current scoring systems that are used to predict
postoperative mortality and complications following cardiac surgery perform poorly in the
elderly population and do not take into account frailty. Moreover they are designed to
predict mortality and complications and are not validated to predict patient reported outcome
measures such as quality of life or functional status. The aim of the AGE study is assess the
value of frailty factors in predicting an improvement in quality of life one year after
cardiac surgery.
Methods:
The AGE study is a prospective observational cohort study. All patients aged 70 years or
older, scheduled for cardiac surgery, mentally competent and have signed informed consent are
eligible for the study. During routine preoperative screening patients will be screened for
frailty using different questionnaires and physical tests. The battery of tests exist of
Short Form 36 (SF36), Multi Nutritional Assessment (MNA), Mini Mental State Examination
(MMSE) and Nagi's scale for disability, Three physical tests: five meter walking speed, timed
get up and go test and hand grip strength. A non-invasive measurement of Advanced Glycation
Endproducts (AGEs) and a medication review. A blood sample will be taken to determine vitamin
status, iron deficiency, pre-operative inflammatory parameters, CMV status, pneumococcal
carriage and cardiac biomarkers. After surgery electronic patients charts will be studied to
score postoperative complications or mortality. Three months and one year after cardiac
surgery patients will receive SF-36 and World Health Organization Disability Assessment
Schedule (WHODAS) 2.0 questionnaires to determine quality of life and functional status.
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