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Anesthesia Geriatric Evaluation and Quality of Life After Cardiac Surgery

Anesthesia Geriatric Evaluation and the Prediction of Quality of Life in Elderly Cardiac Surgery Patients

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02535728
Acronym
AGE
Enrollment
577
Registered
2015-08-31
Start date
2015-07-31
Completion date
2017-12-01
Last updated
2018-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Quality of Life

Keywords

Frail Elderly, Cardiac Surgical Procedure, Risk Assessment, Quality of Life

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.

Interventions

None listed

Sponsors

St. Antonius Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Aged 70 years or older * Mentally competent * Planned cardiac surgery (coronary, valvular, rhythm, aortic or combination of those) * Signed informed consent

Design outcomes

Primary

MeasureTime frameDescription
Quality of Life Assessed by Short Form-36 (SF-36)12 months after surgeryAssessed by Short Form-36 (SF-36)

Secondary

MeasureTime frameDescription
Psychosocial or physical functioning Assessed by World Health Organisation Disability Assessment Schedule 2.03 and 12 months after surgeryAssessed by World Health Organisation Disability Assessment Schedule 2.0 (WHODAS 2.0)
Incidence of postoperative complications30 days after surgeryPostoperative 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).
Quality of Life Assessed by Short Form-36 (SF-36)3 months after surgeryAssessed by Short Form-36 (SF-36)
Length of stay in hospital and ICUPost-Surgery. The expected length of stay in the ICU is 1 to 5 days and in hospital 5 to 10 days.
Postoperative delirium30 daysDelirium according to intensive care delirium screening (ICDSC) or delirium observation screening (DOS)
Mortality30 days and 12 months after surgery

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026