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

NCT06608953 | Enrolling By Invitation DMC

• 2 other identifiers: 246/62TCTR20220202008
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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

Keywords

Enhanced external counterpulsation; Hemodialysis; Arterial stiffness; Pulse wave velocity; Central aortic blood pressure

Outcome Measures

Primary Outcomes (1)

• Pulse wave velocity

  Pulse wave velocity is a well-proven marker of arterial stiffness.

  Baseline, 1.5 months, and 3 months of research

Study Arms (2)

Enhanced external counterpulsation (intervention) group

EXPERIMENTAL

Recieving enhanced external counterpulsation application during hemodialysis

Device: Enhanced external counterpulsation

Controlled group

NO INTERVENTION

Recieve standard hemodialysis with optimal medical care

Interventions

Enhanced external counterpulsation 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.

Enhanced external counterpulsation (intervention) group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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 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
• Pregnant patients
• Patients who not willing to give a consent or who cannot legally give a consent

Sponsors & Collaborators

• Thana Thongsricome, MD: lead

Study Sites (1)

Faculty of Medicine, Chulalongkorn University

Bangkok, Bangkok, 10330, Thailand

Location

Related Publications (1)

• 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 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Dana analysis personnels are blinded to the reaserch arms. The subjects are not blinded to the treatment (not sham-controlled).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator

Model Details: Non sham-controlled, randomized study

Study Record Dates

• First Submitted: September 20, 2024
• First Posted: September 23, 2024
• Study Start: February 13, 2020
• Primary Completion: February 13, 2025
• Study Completion: March 31, 2025
• Last Updated: September 23, 2024

Record last verified: 2024-09

Locations

TH (1)