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

Not Applicable

• Conditions: Hemodialysis
• Interventions: Device: Enhanced external counterpulsation

• Registration Number: NCT06608953
• Lead Sponsor: Thana Thongsricome, MD

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-02-13
• Status Verified: 2024-09
• Study First Submitted: 2024-09-20
• Study First Submitted QC: 2024-09-20
• Last Update Submitted: 2024-09-20
• Study First Posted: 2024-09-23
• Last Update Posted: 2024-09-23
• Primary Completion: 2025-02-13
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Enhanced external counterpulsation (intervention) group	Enhanced external counterpulsation	Recieving enhanced external counterpulsation application during hemodialysis

Primary Outcome Measures

Name	Time	Method
Pulse wave velocity	Baseline, 1.5 months, and 3 months of research	Pulse wave velocity is a well-proven marker of arterial stiffness.

Trial Locations

Locations (1)

Faculty of Medicine, Chulalongkorn University; 🇹🇭 Bangkok, Thailand