Applying Pulse Wave Analysis to Predict Intradialytic Hypotension

Completed

• Conditions: Intradialytic Hypotension
• Interventions: Diagnostic Test: intradialytic hypotension episode

• Registration Number: NCT04180514
• Lead Sponsor: China Medical University, Taiwan

Brief Summary

Intradialytic hypotension (IDH) is a common complication during hemodialysis in patients with chronic kidney disease and may increase the mortality. This study aimed to investigate whether pulse wave analysis could be the predictor of IDH.

In this study, patients under regular hemodialysis were enrolled from Taoyuan Chang Gung memorial hospital. Subjects were evaluated by pulse wave instrument, heart rate variability analyzer and Constitution in Chinese Medicine Questionnaire before hemodialysis. According to the definitions of IDH, subjects in study group and control group were confirmed by the dialysis records. Furthermore, repeated examinations were done for 3 hemodialysis to investigate the possible predictive factors for IDH.

Detailed Description

Intradialytic hypotension (IDH) is a common complication during hemodialysis in patients with chronic kidney disease and may increase the mortality. This study aimed to investigate whether pulse wave analysis could be the predictor of IDH.

In this study, patients under regular hemodialysis were enrolled from Taoyuan Chang Gung memorial hospital. Subjects were evaluated by pulse wave instrument, heart rate variability analyzer and Constitution in Chinese Medicine Questionnaire before hemodialysis. According to the definitions of IDH, subjects in study group and control group were confirmed by the dialysis records. Furthermore, repeated examinations were done for 3 hemodialysis to investigate the possible predictive factors for IDH.

Study Timeline

• Study Start: 2014-09-01
• Primary Completion: 2015-01-31
• Study Completion: 2016-12-17
• Study First Submitted: 2019-11-26
• Study First Submitted QC: 2019-11-26
• Study First Posted: 2019-11-27
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-03
• Last Update Posted: 2019-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• patients under regular hemodialysis (3 times per week) in last 3 months

Exclusion Criteria

• arrhythmia
• artery-vein anastomoses on both arms
• other conditions which might interfere the evaluation of pulse wave analysis and heart rate variability analysis

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Intradialytic hypotension	intradialytic hypotension episode	subjects with intradialytic hypotension episode

Primary Outcome Measures

Name	Time	Method
Pulse wave analysis	within 2 hours before regular dialysis	Pulse wave analysis
Heart rate variability	within 2 hours before regular dialysis	Heart rate variability
Constitution in Chinese Medicine Questionnaire	within 2 hours before regular dialysis	Constitution in Chinese Medicine Questionnaire