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

NCT ID: NCT06608953

Last Updated: 2024-09-23

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-13
• Study Completion Date: 2025-03-31

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.

Conditions

Hemodialysis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Enhanced external counterpulsation (intervention) group

Recieving enhanced external counterpulsation application during hemodialysis

Group Type: EXPERIMENTAL

Enhanced external counterpulsation

Intervention Type: DEVICE

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.

Controlled group

Recieve standard hemodialysis with optimal medical care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Thana Thongsricome, MD

OTHER

Sponsor Role: lead

Responsible Party

Thana Thongsricome, MD

Principal investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Faculty of Medicine, Chulalongkorn University

Bangkok, Bangkok, Thailand

Countries

Thailand

References

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.

Reference Type: BACKGROUND

PMID: 37899762 (View on PubMed)

Other Identifiers

TCTR20220202008

Identifier Type: OTHER

Identifier Source: secondary_id

246/62

Identifier Type: -

Identifier Source: org_study_id