NCT06608953Enrolling By Invitation不适用
A Prospective Randomized Controlled Trial of Effect of Enhanced External Counter Pulsation to Arterial Stiffness in Chronic Hemodialysis Patient
Thana Thongsricome, MD1 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2020年2月13日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Pulse wave velocity
研究概览
简要总结
The objectives of this study are;
- To study effect of Enhanced External Counter Pulsation on arterial stiffness, as measured by pulse wave velocity, compared to standard hemodialysis treatment.
- To study effect of Enhanced External Counter Pulsation on central aortic blood pressure compared to standard hemodialysis treatment.
- To study effect of Enhanced External Counter Pulsation on cardiac index decline during hemodialysis compared to standard hemodialysis treatment.
- To study effect of Enhanced External Counter Pulsation on intradialytic hypotension events compared to standard hemodialysis treatment.
- To study effect of Enhanced External Counter Pulsation on blood biomarkers for endothelial dysfunction and vascular inflammation compared to standard hemodialysis treatment.
- To identify any adverse events from utilizing Enhanced External Counter Pulsation, such as pain or uncomfortable feeling, or even uncontrol hypertension.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Dana analysis personnels are blinded to the reaserch arms. The subjects are not blinded to the treatment (not sham-controlled).
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 years old or older
- •Patients received hemodialysis at King Chulalongkorn Memorial Hospital for at least 3 months
- •Patients received hemodialysis frequency for at least 3 times/week with adequate hemodialysis, named single pool Kt/V of 1.2 or more, as calculated by Chula urea kinetic model
- •Patients achieving proper dry weight, as determined by clinical assessment or by body composition monitoring (Fresineus company)
排除标准
- •Patients with severe or unstable disease required emergent specific treatment such as severe infection or hemodynamic instability
- •Patients with acute coronary syndrome within 1 month
- •Patients received coronary artery bypass graft surgery or percutaneous transluminal coronary angioplasty within 3 months
- •Patients with severe valvular heart disease and hypertrophic obstructive cardiomyopathy known before inclusion or detected by pre - allocation (within 12 months) echocardiographic assessment
- •Patients with cardiac arrhythmia including atrial fibrillation or atrial flutter known before inclusion or detected by pre - allocation (within 12 months) 12 - lead electrocardiography
- •Patients with known or suspected deep vein thrombosis or peripheral arterial disease
- •Patients with thoracic aortic aneurysm detected pre - allocation (within 12 months) echocardiography or abdominal aortic aneurysm detected by pre - allocation (within 12 months) abdominal ultrasonography
- •Patients with bleeding diathesis other than uremic bleeding, including anticoagulants use, but antiplatelets or local thrombolytics for vascular access stenosis/thrombosis are not included
- •Patients with uncontrolled hypertension, defined as systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg
- •Patients with severe pulmonary hypertension known before inclusion or detected by pre - allocation (within 12 months) echocardiographic assessment
- •Pregnant patients
- •Patients who not willing to give a consent or who cannot legally give a consent
研究组 & 干预措施
Enhanced external counterpulsation (intervention) group
Experimental
Recieving enhanced external counterpulsation application during hemodialysis
干预措施: Enhanced external counterpulsation (Device)
Controlled group
No Intervention
Recieve standard hemodialysis with optimal medical care
结局指标
主要结局
Pulse wave velocity
时间窗: Baseline, 1.5 months, and 3 months of research
Pulse wave velocity is a well-proven marker of arterial stiffness.
次要结局
未报告次要终点
研究者
Thana Thongsricome, MD
Principal investigator
Chulalongkorn University
研究点 (1)
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