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Enrolling by invitation NCT06608953

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

No phase Interventional Hemodialysis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Enhanced external counterpulsation.
Who it may be relevant to
Registry conditions: Hemodialysis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Thailand
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Device Enhanced external counterpulsation
    A device applying external pneumatic cuff pressure to the lower limbs, thighs, and buttock sequentially in the diastolic phase synchronouslty with electrocardiography to assist the cardiac function via diastolic augmentation mechanism.

Primary outcome measures

  • Pulse wave velocity [Time frame: Baseline, 1.5 months, and 3 months of research]

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 \> 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Thailand · 1 center
  • Faculty of Medicine, Chulalongkorn University — Bangkok

Publications

  • 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. PMID 37899762

Identifiers

NCT: NCT06608953 · 246/62 · TCTR20220202008

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗