Status:
ENROLLING_BY_INVITATION
A Prospective Randomized Controlled Trial of Effect of Enhanced External Counter Pulsation to Arterial Stiffness in Chronic Hemodialysis Patient
Lead Sponsor:
Thana Thongsricome, MD
Conditions:
Hemodialysis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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...
Eligibility Criteria
Inclusion
- Inclusion criteria
- 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)
- Exclusion criteria
- 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
Exclusion
Key Trial Info
Start Date :
February 13 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2025
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT06608953
Start Date
February 13 2020
End Date
March 31 2025
Last Update
September 23 2024
Active Locations (1)
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1
Faculty of Medicine, Chulalongkorn University
Bangkok, Bangkok, Thailand, 10330