Applying Pulse Wave Analysis to Predict Intradialytic Hypotension

NCT04180514 | Completed FDA Device

• 1 other identifier: IDH-pulse
• Study Type: observational
• Target: 70
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Intradialytic Hypotension

Keywords

intradialytic hypotension; pulse wave analysis; heart rate variability; Constitution in Chinese Medicine Questionnaire

Outcome Measures

Primary Outcomes (3)

• Pulse wave analysis

  Pulse wave analysis

  within 2 hours before regular dialysis

• Heart rate variability

  Heart rate variability

  within 2 hours before regular dialysis

• Constitution in Chinese Medicine Questionnaire

  Constitution in Chinese Medicine Questionnaire

  within 2 hours before regular dialysis

Study Arms (2)

Intradialytic hypotension

subjects with intradialytic hypotension episode

Diagnostic Test: intradialytic hypotension episode

Non-intradialytic hypotension

subjects without intradialytic hypotension episode

Interventions

intradialytic hypotension episode DIAGNOSTIC_TEST

Intradialytic hypotension episode under regular hemodialysis

Intradialytic hypotension

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients under regular hemodialysis in Chang Gung Memorial Hospital

You may qualify if:

• patients under regular hemodialysis (3 times per week) in last 3 months

You may not qualify if:

• arrhythmia
• artery-vein anastomoses on both arms
• other conditions which might interfere the evaluation of pulse wave analysis and heart rate variability analysis

Sponsors & Collaborators

• China Medical University, Taiwan: lead
• Chang Gung Memorial Hospital: collaborator
• Taipei Veterans General Hospital, Taiwan: collaborator

Study Officials

• Ming-Yang Chang, Doctor

  Chang Gung Memorial Hospital, Taoyuan, Taiwan.

  STUDY DIRECTOR

• Hen-Hong Chang, Doctor

  China Medical University, Taichung

  STUDY CHAIR

• Han-Kuei Wu, Doctor

  China Medical University, Taichung, Taiwan.

  PRINCIPAL INVESTIGATOR

• Hao-Min Cheng, Doctor

  Taipei Veterans General Hospital, Taipei, Taiwan.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, School of Post-Baccalaureate Chinese Medicine

Study Record Dates

• First Submitted: November 26, 2019
• First Posted: November 27, 2019
• Study Start: September 1, 2014
• Primary Completion: January 31, 2015
• Study Completion: December 17, 2016
• Last Updated: December 5, 2019

Record last verified: 2019-12