A Prospective Randomized Controlled Trial of Effect of Enhanced External Counter Pulsation to Arterial Stiffness in Chronic Hemodialysis Patient (EECP in HD)

Thana Thongsricome, MD

Status

Invitation-only

Conditions

Hemodialysis

Treatments

Device: Enhanced external counterpulsation

Study type

Interventional

Funder types

Other

Identifiers

NCT06608953

246/62

TCTR20220202008 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

14 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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