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临床试验/NCT02992587
NCT02992587Unknown不适用

Frailty In Cardiac Surgery Copenhagen Study

Rigshospitalet, Denmark0 个研究点目标入组 600 人开始时间: 2016年2月最近更新:
适应症

试验速览

阶段
不适用
入组人数
600
主要终点
Primary outcome: In this study the primary outcome will be 30-day all-cause mortality in frail vs non-frail patients (hospital mortality or death within 30 days postoperatively).

研究概览

简要总结

Background:

Over the past decades there have been seen an increase in life expectancy in Denmark. One of the consequences is that the patients who need heart surgery have a higher average age and some of these patients have a fragile physique that increases the risks of major surgery.

In cardiac surgery, there are different types of scoring system for assessing the preoperative risk of death associated with surgery. Among them are EuroSCORE and STS systems the most used.

This study evaluate the preoperative risk using the frailty score system, CAF (comprehensive assessment of frailty), based on an assessment of the patient's physical condition. If the patient has a lower than expected physical condition, the patient is frail. The assessment of the physical condition generated from questions about the patient's medical history and physical activity as well as performing less physical tests, consisting of strength, balance and walking speed.

Purpose:

A prospective observational study, who investigates how many of the patients who must undergo heart surgery, that is frail. Then compare the patients who are frail with non-frail patients in terms of complications, mortality and quality of life after the procedure. By use of CAF score the patients are scored frail or non-frail. There is planned a further study which compare degree of kidney injury in frail with non-frail patients. Our assumption is that patients which are frail, have an increased risk of complications and longer hospital stay, higher consumption of intensive days and more readmissions. Using frailty score in combination with the existing score systems EuroSCORE and STS score, are believed to be a better predictor of complications following heart surgery.

Method:

FICS study is a prospective observational study of patients undergoing cardiac surgery in the cardiothoracic department of Rigshospitalet. Planned to enroll 600 patients over a two year period. The study consists of various smaller physical test and questions. Which is used to assess whether the patient is frail and not frail.

Postoperatively follow-up after 30 days with a phone call and after 12 months through danish data register. At the both follow-up times, data are collected on the somatic readmissions / diagnoses and vital status through the national register and review of relevant journal notes. Afterwards comparing complications and mortality.

Who can enter:

One patients can be included if the following criteria are met: Age> 65 years, Elective or subacute surgery, CABG (coronary artery bypass grafting),valve substitution or combination of these

If one or more of the following criteria are met, the patient is not included in the study:

Acute surgery, Clinical unstable, Severe neuropsychiatric impairment, Uncooperative (psychiatric diagnosis) and Re-operations.

Side effects, risks and disadvantages:

Today preoperative risk assessment are assessed by EuroSCORE. Introduction of CAF, frailty score will not expose patients to the risk or side effect, since the course or treatment does not change.

Economy:

There are considered that the study are economically justified, since hypothetically this would lead to fewer readmissions, fewer days in intensive care and shorter hospital.

Acquisition:

The patients will in this trial be over 65 years old and must have completed elective or subacute cardiac surgery. They will receive participant information and thus the opportunity to read about the study before the first appearance.

At first appearance they meet our project assistant and get here verbal information about the study, where also questions can be answered. Subsequently, the patients will be asked to sign a consent form.

Publication of test results / research ethics statement:

The knowledge and results obtained through the survey will provide essential scientific information of significance for the future course and treatment of patients undergoing cardiac surgery with regard to the number of hospital days, intensive days and readmissions. Thus, the investigator believes that the study is appropriate and ethically

详细描述

Background:

In general, patients referred to cardiac surgery are aging. An increasing number of patients are now older than 70 years. [1]This older population of patients undergoing cardiac surgery often has several comorbidities and has an increased risk of complications and mortality compared to the younger patients.[1,2] Furthermore, several studies have shown that elderly patients with cardiovascular diseases may be frail. Frailty is a term used to assess the true biological status of a patient and defined as a patient's impaired resistance to stressors due to a decline in physiologic reserve.[3-8] In cardiac surgery there are several risk scores to assess 30-day mortality exists. The most common are the European system for cardiac operative risk evaluation (EuroSCORE) I, EuroSCORE II and the Society of Thoracic Surgeons (STS) score. However, the EuroSCORE seems to have a tendency to overestimate the perioperative risk in the elderly population and opposite the STS score a tendency to underestimate the risk. One of the reasons for this may be that none of the risk scores incorporate the biological status of the patients.[9-11] Within the last 5 years a few studies evaluating different 'frailty scores' in cardiac patients has been published. [3-6,8,12-16] None of these frailty risk scores are fully validated and therefore widely adopted. In a German single center study of 400 patients undergoing elective cardiac surgery and aged 74 or above frailty was assessed by the comprehensive assessment of frailty (CAF) score. The CAF scores assess weakness, self-reported exhaustion, slowness of gait speed, low activity and physical performance. [14,15] The CAF score correlates well with the EuroSCORE and STS score, but is a very complex and time consuming risk score. In an effort to make the test more clinical practical a simpler version of the CAF score has been developed. The 'frailty predicts death one year after elective cardiac surgery test' (FORECAST) includes; chair rise, self-reported weakness, stair climbing, two physicians estimation of frailty and serum creatinine level. [14,17]

Aim:

In an observational prospective study, we will identify and describe the number of frail patients undergoing first time cardiac surgery in our department, compare the risk of short-term and long-term complications and compare quality of life in frail versus non-frail patients. Frailty will be assessed with the CAF score. In a substudy we will analyze the risk of renal insufficiency.

Hypothesis:

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

  • All patients aged above 65 years old 2) Patients referred to elective and subacute cardiac surgery 3) All undergoing CABG (coronary artery bypass grafting), valve replacement and CABG with valve replacement.

排除标准

  • Emergency surgery 2) Clinically unstable 3) Severe neuropsychiatric impairment 4) No cooperation (psychiatric diagnosis). 5) Reoperations

结局指标

主要结局

Primary outcome: In this study the primary outcome will be 30-day all-cause mortality in frail vs non-frail patients (hospital mortality or death within 30 days postoperatively).

时间窗: 30 days

次要结局

  • MACCE (Major Adverse Cardiac and Cerebrovascular Events) including: - AMI: - Stroke - Mortality(30 days)

研究者

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

Christian Holdflod Møller

Doctor of Medical Science

Rigshospitalet, Denmark

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