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临床试验/NCT02749149
NCT02749149Unknown不适用

Assessment of the Frailty Score in Cardiac Surgery and Its Correlation to Cardiac Postoperative Morbidity and Disability - a Prospective Observational Study

King's College Hospital NHS Trust0 个研究点目标入组 120 人开始时间: 2016年1月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
120
主要终点
Disability-free survival

研究概览

简要总结

This study will assess the benefit in using a frailty score to quantify accurate risk pre-operatively in patients undergoing major cardiac surgery in order to predict morbidity and disability-free survival post-operatively.

详细描述

Increasingly, the group of patients undergoing cardiac surgery are older. Patients that are more elderly and frail are known to have an increase risk of injury to major organs following surgery including the heart, kidneys, and brain, all of which are associated with worse survival or diminished quality of life. It is becoming more important to be able to predict how well patients will fair in cardiac surgery, including predicting risk of complications (such as stroke or heart attacks) as well as long-term survival and quality of life. Currently, scores such as EUROscore can be used with good effect in predicting survival and major complications in cardiac surgery patients. However, frailty - the severity of a patient's weakness or fragility - has emerged as a potential candidate in predicting risk. Recent research has shown frailty score to predict risk of survival and complications following cardiac surgery and suggested to be possibly superior to pre-existing scores. The investigators wish to investigate the possible link between frailty and outcomes following cardiac surgery, in addition to current risk scores. The investigators also wish to determine whether frailty can effectively predict longer-term outcomes such as 'disability-free survival' - a patient-centred score that measures the ability of a patient to lead normal life activities. Patients undergoing major cardiac surgery at King's College Hospital will be recruited, following consent. The study will mainly involve questionnaires at various stages, starting at a pre-operative clinic. After surgery, follow up of patient's progress will be carried out at 3 days in hospital; and at 1 month, 3 months, and 6 months and 1 year via telephone. The investigators expect the results of this observational study to influence further research into the use of frailty risk scoring prior to clinical decisions, and add to the evidence in assessing risk-related outcomes in cardiac surgery.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aged 18 years or over
  • Due to undergo elective cardiac surgery: coronary artery bypass graft (CABG); valve replacement/repair; or transcatheter aortic valve implantation (TAVI) surgery
  • Able to give informed consent
  • Fluency in English

排除标准

  • Emergency cardiac surgery and non-cardiac surgery
  • Inadequate knowledge of English that will prevent patients from completing the consent or undertaking study assessments
  • Severe visual, auditory, or motor handicap
  • Concurrent diseases of the central nervous system,
  • Patients at the extremes of frailty, in whom it would be unethical to perform a full assessment.

结局指标

主要结局

Disability-free survival

时间窗: 1 year

Defined as percentage of participants alive and with a disability score (using World Health Organisation Disability Assessment Schedule 2.0, WHODAS) of less than 25%.

次要结局

  • Delirium(3 days postoperative)
  • Mortality(1 month postoperative)
  • In hospital complications(1 month)
  • Return to theatre(1 month)
  • Length of hospital stay(1 month)

研究者

发起方
King's College Hospital NHS Trust
申办方类型
Other
责任方
Sponsor

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