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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04180514
Other study ID # IDH-pulse
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 1, 2014
Est. completion date December 17, 2016

Study information

Verified date December 2019
Source China Medical University, Taiwan
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 70
Est. completion date December 17, 2016
Est. primary completion date January 31, 2015
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
intradialytic hypotension episode
Intradialytic hypotension episode under regular hemodialysis

Locations

Country Name City State
n/a

Sponsors (3)

Lead Sponsor Collaborator
China Medical University, Taiwan Chang Gung Memorial Hospital, Taipei Veterans General Hospital, Taiwan

Outcome

Type Measure Description Time frame Safety issue
Primary Pulse wave analysis Pulse wave analysis within 2 hours before regular dialysis
Primary Heart rate variability Heart rate variability within 2 hours before regular dialysis
Primary Constitution in Chinese Medicine Questionnaire Constitution in Chinese Medicine Questionnaire within 2 hours before regular dialysis
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