Clinical trial NCT06608953: A Prospective Randomized Controlled Trial of Effect of Enhanced External Counter Pulsation to Arterial Stiffness in Chronic Hemodialysis Patient
Official title: A Prospective Randomized Controlled Trial of Effect of Enhanced External Counter Pulsation to Arterial Stiffness in Chronic Hemodialysis Patient
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Hemodialysis
Keywords: Enhanced external counterpulsation
Hemodialysis
Arterial stiffness
Pulse wave velocity
Central aortic blood pressure
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2024-09-23
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Non sham-controlled, randomized study
Primary purpose: TREATMENT

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 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.


Eligibility 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 \&gt; 160 mmHg or diastolic blood pressure \&gt; 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

Primary outcomes:
measure: Pulse wave velocity
timeFrame: Baseline, 1.5 months, and 3 months of research
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Faculty of Medicine, Chulalongkorn University
Study officials:
References:
citation: Thongsricome T, Kositanurit W, Siwamogsatham S, Tiranathanagul K. Enhanced external counterpulsation, focusing on its effect on kidney function, and utilization in patients with kidney diseases: a systematic review. Asian Biomed (Res Rev News). 2023 Oct 26;17(5):208-221. doi: 10.2478/abm-2023-0062. eCollection 2023 Oct.