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Completed

NCT Number: NCT04180514

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.

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Key information

Conditions

Intradialytic Hypotension

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

intradialytic hypotension episode

Diagnostic Test

Intradialytic hypotension episode under regular hemodialysis

Primary outcomes

  1. Pulse wave analysis

    Time frame: within 2 hours before regular dialysis

    Pulse wave analysis

  2. Heart rate variability

    Time frame: within 2 hours before regular dialysis

    Heart rate variability

  3. Constitution in Chinese Medicine Questionnaire

    Time frame: within 2 hours before regular dialysis

    Constitution in Chinese Medicine Questionnaire

Sponsors and collaborators

Lead sponsor

China Medical University, Taiwan

Other

Collaborators

  • Chang Gung Memorial Hospital
  • Taipei Veterans General Hospital, Taiwan

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Nov 27, 2019
Registry last updated
Dec 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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