Applying Pulse Wave Analysis to Predict Intradialytic Hypotension

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 Overview

• Status: Completed
• Conditions: Intradialytic Hypotension
• Intervention / Treatment: Diagnostic test: intradialytic hypotension episode

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 Type: Observational
• Enrollment (Actual): 70

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients under regular hemodialysis in Chang Gung Memorial Hospital

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Intradialytic hypotension; subjects with intradialytic hypotension episode	Diagnostic test: intradialytic hypotension episode; Intradialytic hypotension episode under regular hemodialysis
Non-intradialytic hypotension; subjects without intradialytic hypotension episode

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pulse wave analysis	Pulse wave analysis	within 2 hours before regular dialysis
Heart rate variability	Heart rate variability	within 2 hours before regular dialysis
Constitution in Chinese Medicine Questionnaire	Constitution in Chinese Medicine Questionnaire	within 2 hours before regular dialysis

Collaborators and Investigators

• Sponsor: China Medical University, Taiwan
• Collaborators: Chang Gung Memorial Hospital; Taipei Veterans General Hospital, Taiwan
• Investigators: Study Director: Ming-Yang Chang, Doctor, Chang Gung Memorial Hospital, Taoyuan, Taiwan.; Study Chair: Hen-Hong Chang, Doctor, China Medical University, Taichung; Principal Investigator: Han-Kuei Wu, Doctor, China Medical University, Taichung, Taiwan.; Study Director: Hao-Min Cheng, Doctor, Taipei Veterans General Hospital, Taipei, Taiwan.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2014
• Primary Completion (Actual): January 31, 2015
• Study Completion (Actual): December 17, 2016

Study Registration Dates

• First Submitted: November 26, 2019
• First Submitted That Met QC Criteria: November 26, 2019
• First Posted (Actual): November 27, 2019

Study Record Updates

• Last Update Posted (Actual): December 5, 2019
• Last Update Submitted That Met QC Criteria: December 3, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: heart rate variability; intradialytic hypotension; pulse wave analysis; Constitution in Chinese Medicine Questionnaire
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypotension
• Other Study ID Numbers: IDH-pulse

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No