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临床试验/NCT02535728
NCT02535728已完成不适用

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

St. Antonius Hospital1 个研究点 分布在 1 个国家目标入组 577 人开始时间: 2015年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
577
试验地点
1
主要终点
Quality of Life Assessed by Short Form-36 (SF-36)

研究概览

简要总结

A prospective observational cohort study to assess the predictive value of preoperative frailty on postoperative quality of life in cardiac surgery patients.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
70 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 未提供

结局指标

主要结局

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

时间窗: 12 months after surgery

Assessed by Short Form-36 (SF-36)

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

dr. P. Noordzij

dr. P. Noordzij, MD PhD

St. Antonius Hospital

研究点 (1)

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