Intradialytic HypotensionNCT04180514
Applying Pulse Wave Analysis to Predict Intradialytic Hypotension
An observational study of Intradialytic Hypotension, run by China Medical University, Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Intradialytic Hypotension
- What is being tested?
- intradialytic hypotension episode
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2014to 17 Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients under regular hemodialysis in Chang Gung Memorial Hospital
Who may be able to join
- patients under regular hemodialysis (3 times per week) in last 3 months
Who cannot join
- arrhythmia
- artery-vein anastomoses on both arms
- other conditions which might interfere the evaluation of pulse wave analysis and heart rate variability analysis
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.
Read the 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.
- Conditions
- Intradialytic Hypotension
- Being tested
- intradialytic hypotension episode
- Keywords
- intradialytic hypotension, pulse wave analysis, heart rate variability, Constitution in Chinese Medicine Questionnaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intradialytic hypotension episodeDiagnostic test
Intradialytic hypotension episode under regular hemodialysis
| Study group | Role | What they receive |
|---|---|---|
| Intradialytic hypotension | subjects with intradialytic hypotension episode Receives: Diagnostic Test: intradialytic hypotension episode | |
| Non-intradialytic hypotension | subjects without intradialytic hypotension episode |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulse wave analysis
Pulse wave analysis
Measured: within 2 hours before regular dialysis
Heart rate variability
Heart rate variability
Measured: within 2 hours before regular dialysis
Constitution in Chinese Medicine Questionnaire
Constitution in Chinese Medicine Questionnaire
Measured: within 2 hours before regular dialysis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2019
- Study start1 Sep 2014
- Primary completion31 Jan 2015
- Study completion17 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intradialytic HypotensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- China Medical University, Taiwan
- Sponsor type
- University, hospital or other
- Collaborators
- Chang Gung Memorial Hospital, Taipei Veterans General Hospital, Taiwan
- Responsible party
- Principal investigator, Han-Kuei Wu, China Medical University, Taiwan
- Investigators
- Ming-Yang Chang, Doctor, Study director, Chang Gung Memorial Hospital, Taoyuan, Taiwan.Hen-Hong Chang, Doctor, Study chair, China Medical University, TaichungHan-Kuei Wu, Doctor, Principal investigator, China Medical University, Taichung, Taiwan.Hao-Min Cheng, Doctor, Study director, Taipei Veterans General Hospital, Taipei, Taiwan.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04180514
- Sponsor's protocol ID
- IDH-pulse
- Status last verified
- Dec 2019
- First submitted
- 26 Nov 2019
- Last updated
- 5 Dec 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Applying Pulse Wave Analysis to Predict Intradialytic Hypotension
- ClinicalTrials.gov ID
- NCT04180514
- Acronym / sponsor ID
- IDH-pulse
- Conditions
- Intradialytic Hypotension
- Keywords
- intradialytic hypotension, pulse wave analysis, heart rate variability, Constitution in Chinese Medicine Questionnaire
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- China Medical University, TaiwanUniversity, hospital or other
- Collaborators
- Chang Gung Memorial Hospital, Taipei Veterans General Hospital, Taiwan
- Study start
- 1 Sep 2014 (actual)
- Primary completion
- 31 Jan 2015 (actual)
- Study completion
- 17 Dec 2016 (actual)
- First posted
- 27 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intradialytic hypotension | – | Diagnostic Test: intradialytic hypotension episodesubjects with intradialytic hypotension episode |
| Non-intradialytic hypotension | – | –subjects without intradialytic hypotension episode |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients under regular hemodialysis in Chang Gung Memorial Hospital
Key inclusion criteria (1 listed)
- patients under regular hemodialysis (3 times per week) in last 3 months
Key exclusion criteria (3 listed)
- arrhythmia
- artery-vein anastomoses on both arms
- other conditions which might interfere the evaluation of pulse wave analysis and heart rate variability analysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intradialytic hypotension episodeIntradialytic hypotension episode under regular hemodialysis | Diagnostic test | Intradialytic hypotension |
Primary outcome
Pulse wave analysis
Time frame: within 2 hours before regular dialysis
Pulse wave analysis
Heart rate variability
Time frame: within 2 hours before regular dialysis
Heart rate variability
Constitution in Chinese Medicine Questionnaire
Time frame: within 2 hours before regular dialysis
Constitution in Chinese Medicine Questionnaire
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2019.
- Individual participant dataSharing planned: Undecided
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Improved Hemodynamic Tolerance of Intermittent Hemodialysis Sessions in Intensive Care Unite Using Citrate- vs Acetate-based Dialysate
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A Pilot Trial of Chinese Medicine for Patients With Dialytic Hypotension
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ming-Yang Chang, Doctor study director
Chang Gung Memorial Hospital, Taoyuan, Taiwan.
Hen-Hong Chang, Doctor study chair
China Medical University, Taichung
Han-Kuei Wu, Doctor principal investigator
China Medical University, Taichung, Taiwan.
Questions about this trial
What is this clinical trial studying?
An observational study of Intradialytic Hypotension, run by China Medical University, Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulse wave analysis (time frame: within 2 hours before regular dialysis). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2019.