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Clinical Trials/NCT02535728
NCT02535728
Completed
Not Applicable

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

St. Antonius Hospital1 site in 1 country577 target enrollmentJuly 2015
ConditionsQuality of Life

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Quality of Life
Sponsor
St. Antonius Hospital
Enrollment
577
Locations
1
Primary Endpoint
Quality of Life Assessed by Short Form-36 (SF-36)
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 2015
End Date
December 1, 2017
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

dr. P. Noordzij

dr. P. Noordzij, MD PhD

St. Antonius Hospital

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Quality of Life Assessed by Short Form-36 (SF-36)

Time Frame: 12 months after surgery

Assessed by Short Form-36 (SF-36)

Secondary Outcomes

  • Quality of Life Assessed by Short Form-36 (SF-36)(3 months after surgery)
  • Incidence of postoperative complications(30 days after surgery)
  • 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)
  • 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)

Study Sites (1)

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