Applying Pulse Wave Analysis to Predict Intradialytic Hypotension

NCT ID: NCT04180514

Last Updated: 2019-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-09-01

Study Completion Date

2016-12-17

Brief Summary

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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

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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.

Conditions

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Intradialytic Hypotension

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Intradialytic hypotension

subjects with intradialytic hypotension episode

intradialytic hypotension episode

Intervention Type DIAGNOSTIC_TEST

Intradialytic hypotension episode under regular hemodialysis

Non-intradialytic hypotension

subjects without intradialytic hypotension episode

No interventions assigned to this group

Interventions

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intradialytic hypotension episode

Intradialytic hypotension episode under regular hemodialysis

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chang Gung Memorial Hospital

OTHER

Sponsor Role collaborator

Taipei Veterans General Hospital, Taiwan

OTHER_GOV

Sponsor Role collaborator

China Medical University, Taiwan

OTHER

Sponsor Role lead

Responsible Party

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Han-Kuei Wu

Assistant Professor, School of Post-Baccalaureate Chinese Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ming-Yang Chang, Doctor

Role: STUDY_DIRECTOR

Chang Gung Memorial Hospital, Taoyuan, Taiwan.

Hen-Hong Chang, Doctor

Role: STUDY_CHAIR

China Medical University, Taichung

Han-Kuei Wu, Doctor

Role: PRINCIPAL_INVESTIGATOR

China Medical University, Taichung, Taiwan.

Hao-Min Cheng, Doctor

Role: STUDY_DIRECTOR

Taipei Veterans General Hospital, Taipei, Taiwan.

Other Identifiers

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IDH-pulse

Identifier Type: -

Identifier Source: org_study_id

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