Applying Pulse Wave Analysis to Predict Intradialytic Hypotension

Intradialytic Hypotension Clinical Trial

Official title:

Applying Pulse Wave Analysis to Predict Intradialytic Hypotension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04180514
• Other study ID #: IDH-pulse
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Hypotension
• Intradialytic Hypotension

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