Clinical trial NCT02535728: Anesthesia Geriatric Evaluation and Quality of Life After Cardiac Surgery
Official title: Anesthesia Geriatric Evaluation and the Prediction of Quality of Life in Elderly Cardiac Surgery Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Quality of Life
Keywords: Frail Elderly
Cardiac Surgical Procedure
Risk Assessment
Quality of Life
Lead sponsor: St. Antonius Hospital
Sponsor class: OTHER
First posted: 2015-08-31
Enrollment: 577
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients planned for elective cardiac surgery and aged 70 years or older.

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.

Eligibility criteria: Inclusion Criteria:

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

Primary outcomes:
measure: Quality of Life Assessed by Short Form-36 (SF-36)
timeFrame: 12 months after surgery
Secondary outcomes:
measure: Quality of Life Assessed by Short Form-36 (SF-36)
timeFrame: 3 months after surgery
measure: Psychosocial or physical functioning Assessed by World Health Organisation Disability Assessment Schedule 2.0
timeFrame: 3 and 12 months after surgery
measure: Incidence of postoperative complications
timeFrame: 30 days after surgery
measure: Mortality
timeFrame: 30 days and 12 months after surgery
measure: Length of stay in hospital and ICU
timeFrame: Post-Surgery. The expected length of stay in the ICU is 1 to 5 days and in hospital 5 to 10 days.
measure: Postoperative delirium
timeFrame: 30 days
Other outcomes:
Locations:
city: Nieuwegein
country: Netherlands
facility: St Antonius hospital
state: Utrecht
Study officials:
affiliation: St. Antonius Hospital
name: Peter G Noordzij, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Arends BC, Timmerman L, Vernooij LM, Verwijmeren L, Biesma DH, van Dongen EPA, Noordzij PG, van Oud-Alblas HJB. Preoperative frailty and chronic pain after cardiac surgery: a prospective observational study. BMC Anesthesiol. 2022 Jul 1;22(1):201. doi: 10.1186/s12871-022-01746-x.
citation: Verwijmeren L, Bosma M, Vernooij LM, Linde EM, Dijkstra IM, Daeter EJ, Van Dongen EPA, Van Klei WA, Noordzij PG. Associations Between Preoperative Biomarkers and Cardiac Surgery-Associated Acute Kidney Injury in Elderly Patients: A Cohort Study. Anesth Analg. 2021 Sep 1;133(3):570-577. doi: 10.1213/ANE.0000000000005650.
citation: Verwijmeren L, Peelen LM, van Klei WA, Daeter EJ, van Dongen EPA, Noordzij PG. Anaesthesia geriatric evaluation to guide patient selection for preoperative multidisciplinary team care in cardiac surgery. Br J Anaesth. 2020 Apr;124(4):377-385. doi: 10.1016/j.bja.2019.12.042. Epub 2020 Feb 14.