Applying Pulse Wave Analysis to Predict Intradialytic Hypotension

December 3, 2019 updated by: Han-Kuei Wu, China Medical University, Taiwan

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

Intervention / Treatment

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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