Clinical trial NCT04180514: Applying Pulse Wave Analysis to Predict Intradialytic Hypotension
Official title: Applying Pulse Wave Analysis to Predict Intradialytic Hypotension
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intradialytic Hypotension
Keywords: intradialytic hypotension
pulse wave analysis
heart rate variability
Constitution in Chinese Medicine Questionnaire
Lead sponsor: China Medical University, Taiwan
Sponsor class: OTHER
Collaborators: name: Chang Gung Memorial Hospital
name: Taipei Veterans General Hospital, Taiwan
First posted: 2019-11-27
Enrollment: 70
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients under regular hemodialysis in Chang Gung Memorial Hospital

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pulse wave analysis
timeFrame: within 2 hours before regular dialysis
measure: Heart rate variability
timeFrame: within 2 hours before regular dialysis
measure: Constitution in Chinese Medicine Questionnaire
timeFrame: within 2 hours before regular dialysis
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Chang Gung Memorial Hospital, Taoyuan, Taiwan.
name: Ming-Yang Chang, Doctor
role: STUDY_DIRECTOR
affiliation: China Medical University, Taichung
name: Hen-Hong Chang, Doctor
role: STUDY_CHAIR
affiliation: China Medical University, Taichung, Taiwan.
name: Han-Kuei Wu, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Taipei Veterans General Hospital, Taipei, Taiwan.
name: Hao-Min Cheng, Doctor
role: STUDY_DIRECTOR
References: