Anesthesia Geriatric Evaluation and Quality of Life After Cardiac Surgery
- Conditions
- Quality of Life
- Registration Number
- NCT02535728
- Lead Sponsor
- St. Antonius Hospital
- Brief Summary
A prospective observational cohort study to assess the predictive value of preoperative frailty on postoperative quality of life in cardiac surgery patients.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 577
- Aged 70 years or older
- Mentally competent
- Planned cardiac surgery (coronary, valvular, rhythm, aortic or combination of those)
- Signed informed consent
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Quality of Life Assessed by Short Form-36 (SF-36) 12 months after surgery Assessed by Short Form-36 (SF-36)
- Secondary Outcome Measures
Name Time Method Quality of Life Assessed by Short Form-36 (SF-36) 3 months after surgery Assessed by Short Form-36 (SF-36)
Incidence of postoperative complications 30 days after surgery Postoperative complications are scored according to Dutch national guidelines on reporting complications in cardiac surgery and include rethoracotomy, reoperation, bleeding, arrythmia, stroke, myocardial infarction, deep sternal wound infection, pneumonia, urinary tract infection, sepsis, respiratory insufficiency, prolonged respiratory support and renal failure (AKI).
Mortality 30 days and 12 months after surgery Psychosocial or physical functioning Assessed by World Health Organisation Disability Assessment Schedule 2.0 3 and 12 months after surgery Assessed by World Health Organisation Disability Assessment Schedule 2.0 (WHODAS 2.0)
Length of stay in hospital and ICU Post-Surgery. The expected length of stay in the ICU is 1 to 5 days and in hospital 5 to 10 days. Postoperative delirium 30 days Delirium according to intensive care delirium screening (ICDSC) or delirium observation screening (DOS)
Trial Locations
- Locations (1)
St Antonius hospital
🇳🇱Nieuwegein, Utrecht, Netherlands