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【ChiCTR1800016098】擇期心臟手術前復康計劃研究: 隨機對照試驗

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基本信息

登记号

ChiCTR1800016098

试验状态

结束

药物名称

药物类型

规范名称

首次公示信息日的期

2018-05-02

临床申请受理号

靶点

适应症

Patients undergoing elective cardiac surgery (CABG, with/without valvular interventions) Pre-frail and Frail patients

试验通俗题目

擇期心臟手術前復康計劃研究: 隨機對照試驗

试验专业题目

擇期心臟手術前復康計劃研究: 隨機對照試驗

申办单位信息

申请人联系人

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申请人名称

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联系人邮箱

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联系人邮编

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临床试验信息

试验目的

In patients undergoing primary elective cardiac surgery, does prehabilitation during the two months waiting period before surgery compared to no prehabilitation improve postoperative quality of recovery?

试验分类

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试验类型

随机平行对照

试验分期

Ⅲ期

随机化

Randomized

盲法

Single-blind for Investigator/research team

试验项目经费来源

Department of Anaesthesia and Intensive Care, The Chinese University of Hong Kong; Local research grant by the General Research Fund (Pending)

试验范围

目标入组人数

164

实际入组人数

第一例入组时间

2018-07-03

试验终止时间

2023-10-31

是否属于一致性

入选标准

1. Adults undergoing elective primary isolated coronary artery bypass grafting, aortic valve repair/replacement, mitral valve repair/replacement, or combined coronary artery bypass/valve procedures; 2. Prefrail to moderately frail patients with a Clinical Frailty Score of 4-6 at the time of accepting surgery at the outpatient cardiothoracic surgical clinic; 3. Patients with an estimated 8 or more weeks of surgical waiting list time; 4. Agreement on the suitability of the patient for prehabilitation with the attending cardiothoracic surgeon.；

排除标准

1. Patients with unstable or recently unstable cardiac syndrome (New York Heart Association Class IV, critical left main coronary disease, hospitalization for arrhythmias, congestive heart failure or acute coronary syndrome before randomisation); 2. Patients with severe left ventricular obstructive disease (severe aortic or mitral stenosis, dynamic left ventricular outflow obstruction); 3. Redo cardiac surgery; 4. Contraindications for prehabilitation (those with cognitive deficits unable to comply with study procedures, physical limitations precluding rehabilitation and inability to regularly attend outpatient prehabilitation sessions).；

研究者信息

研究负责人姓名

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试验机构

香港中文大學麻醉與重症監護部

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