Hemodialysis-Induced SymptomNCT03856151
To Evaluate the Effects of Heating Device (Electronic Moxibustion) in Patients With Intradialytic Hypotension
A study testing "HEALTHY BOX" Powered heating pad (electronic moxibustion) in people with Hemodialysis-Induced Symptom and Intra-dialytic Hypotension, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
The aim of this study is to investigate the effects of heating device among otherwise stable patients with intradialytic hypotension Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Hemodialysis-Induced Symptom, Intra-dialytic Hypotension
- What is being tested?
- "HEALTHY BOX" Powered heating pad (electronic moxibustion)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteTaiwan
- Study dates
- 17 Apr 2019to 28 Apr 2021
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 20 to 80-years-old
- Willing to sign inform consent
- Weekly hemodialysis 3 times per week, each time at least 180 minutes
- During the past 2 months of hemodialysis, there is symptomatic intra-dialytic hypotension for over 15% of the time or under regular use of Midodrine.
Who cannot join
- Pregnancy or breast-feeding
- Not able to fill out questionnaires
- Severe comorbidities, including cirrhosis, heart failure, autoimmune diseases and cancer
- Diabetic peripheral neuropathy or patients insensitive to heat or unable to effectively express themselves in heated situations
- Undergoing other types of alternative treatment, including Chinese medicine and regional remedies.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to investigate the effects of heating device among otherwise stable patients with intradialytic hypotension
Read the detailed description
Intradialytic hypotension (IDH) is a common complication during hemodialysis (HD) which accounts up to 5 to 30 percent of all dialysis treatment and is associated with increased morbidity and mortality. The etiology of IDH is multifactorial, but intravascular volume depletion, autonomic neuropathy, and decreased cardiac reserve were the main factors. Several approaches were utilized to prevent IDH including adaptation of dialysis prescriptions, lengthening in dialysis time, avoiding food intake during dialysis, as well as limiting interdialytic sodium intake and administration of vasoconstrictor agents. However, it remains necessary to seek novel effective and safe inventions for IDH. To date, no studies have been done to evaluate the effectiveness of acupuncture and traditional moxibustion during HD for safety reasons (eg: risk of bleeding, burns and unpleasant smell). Therefore, the heating device appears to be a non-invasive and safe method for treating IDH. The investigators conduct a clinical trial using infrared heating devices without direct contact to the skin on low temperatures (56±8℃) in treating patients with IDH. 30 eligible participants diagnosed with IDH will be enrolled and divided into Group 1 and Group 2. Treatment 1# will be regular dialysis 3 times per week for 4 weeks. Treatment 2# will be regular dialysis 3 times per week plus "HEALTHY BOX" Powered heating pad on acupoint CV4 at the abdomen for 1 hour during dialysis, also for 4 weeks. For Group 1, each subject will receive Treatment 1# first, for Group 2, Treatment 2# will be received first. Then, it takes 2-week washout period with regular dialysis 3 times per week and make Group 1 and Group 2 crossover. Outcomes will include blood pressure changes, nursing intervention frequencies, IDH frequencies, the degree of cold intolerance, the degree of fatigue after dialysis and recovery time from fatigue after dialysis, the percentage of target ultrafiltration achieved and blood biochemistry. Data will be collected at the beginning of the study (baseline), end of Treatment 1 # , and end of Treatment 2#. Subjective questionnaires will be collected before and after each treatment period. The difference of evaluation scores between baseline and post-treatment will be analyzed using generalized linear mixed model. A value of P < 0.05 will be regarded as statistically significant for the above statistical analyses.
- Being tested
- "HEALTHY BOX" Powered heating pad (electronic moxibustion)
- Keywords
- hemodialysis, Intra-dialytic Hypotension, heating device, electronic moxibustion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"HEALTHY BOX" Powered heating pad (electronic moxibustion)Device
Using heating pad (electronic moxibustion) with insulating materials on low temperatures (56±8℃) in treating patients with intra-dialytic hypotension
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | For Group 1, each subject will receive Treatment 1# first. Then, it takes 2-week washout period with regular dialysis 3 times per week and then receive Treatment 2#.
Treatment 1# will be regular dialysis 3 times per week for 4 weeks. Treatment 2# will be regular dialysis 3 times per week plus "HEALTHY BOX" Powered heating pad on acupoint CV4 at the abdomen for 1 hour during dialysis, also for 4 weeks. Receives: Device: "HEALTHY BOX" Powered heating pad (electronic moxibustion) |
| Group 2 | Active comparator | For Group 2, each subject will receive Treatment 2# first. Then, it takes 2-week washout period with regular dialysis 3 times per week and then receive Treatment 1#.
Treatment 2# will be regular dialysis 3 times per week plus "HEALTHY BOX" Powered heating pad on acupoint CV4 at the abdomen for 1 hour during dialysis, also for 4 weeks.
Treatment 1# will be regular dialysis 3 times per week for 4 weeks. Receives: Device: "HEALTHY BOX" Powered heating pad (electronic moxibustion) |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of frequency of IDH episodes
times of IDH episode according to NADIR, KDOQI criteria
Measured: baseline, Treatment 1, Treatment 2
change of number of nursing interventions during HD
Trendelenburg position, man¬ual reduction of ultrafiltration rate, infusion of isotonic saline or hypertonic fluid, lowering of dialysate temperature
Measured: baseline, Treatment 1, Treatment 2
Secondary outcomes (4)
change of the degree of cold intolerance
from 0 to 100; 0 is not cold, 100 is very cold
Measured: week 0,4,6,10
change of the degree of fatigue after dialysis
scores from 0-10;0 is not tired, 10 is very tired
Measured: before and after Treatment1 & 2
blood pressure changes
systolic, diastolic blood pressure and mean arterial pressure: mmHg
Measured: baseline, Treatment 1, Treatment 2
change of recovery time from fatigue after dialysis
within minutes (0), when arriving home (0), at bedtime (2), the next morning (5), and by next HD (10)
Measured: before and after Treatment1 & 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2019
- Study start17 Apr 2019
- Primary completion20 Apr 2020
- Study completion28 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodialysis-Induced SymptomStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 30 eligible participants diagnosed with IDH will be enrolled and divided randomly and equally into Group 1 and Group 2 . Treatment 1# will be regular dialysis 3 times per week for 4 weeks. Treatment 2# will be regular dialysis 3 times per week plus "HEALTHY BOX" Powered heating pad on acupoint CV4 at the abdomen for 1 hour during dialysis, also for 4 weeks. For Group 1, each subject will receive Treatment 1# first, for Group 2, Treatment 2# will be received first. Then, a 2-week washout period with regular dialysis 3 times per week will be carried out. Group 1 will then receive Treatment 2# and Group 2 will then receive Treatment 1#. Subjective questionnaires will be done before and after each Treatment period.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03856151
- Sponsor's protocol ID
- 201801853A3
- Status last verified
- Jan 2019
- First submitted
- 11 Feb 2019
- Last updated
- 16 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 1. There will be a research number representing the identity. This number will not display the name, ID number, and address. 2. For the results and diagnosis of the visit, the research host will maintain a confidential attitude and carefully maintain the privacy. If research results are published, the identity will remain confidential. 3. Please also understand that if the participant signs the consent form, the participant agrees that the visit record can be directly reviewed by the monitor, auditor, research ethics committee and the competent authority to ensure that the research process and data comply with relevant laws and regulations. These people also promise not to violate the confidentiality of your identity.
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Evaluate the Effects of Heating Device (Electronic Moxibustion) in Patients With Intradialytic Hypotension
- ClinicalTrials.gov ID
- NCT03856151
- Acronym / sponsor ID
- 201801853A3
- Keywords
- hemodialysis, Intra-dialytic Hypotension, heating device, electronic moxibustion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 17 Apr 2019 (actual)
- Primary completion
- 20 Apr 2020 (actual)
- Study completion
- 28 Apr 2021 (actual)
- First posted
- 27 Feb 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.
The aim of this study is to investigate the effects of heating device among otherwise stable patients with intradialytic hypotension
Detailed description
Intradialytic hypotension (IDH) is a common complication during hemodialysis (HD) which accounts up to 5 to 30 percent of all dialysis treatment and is associated with increased morbidity and mortality. The etiology of IDH is multifactorial, but intravascular volume depletion, autonomic neuropathy, and decreased cardiac reserve were the main factors. Several approaches were utilized to prevent IDH including adaptation of dialysis prescriptions, lengthening in dialysis time, avoiding food intake during dialysis, as well as limiting interdialytic sodium intake and administration of vasoconstrictor agents. However, it remains necessary to seek novel effective and safe inventions for IDH. To date, no studies have been done to evaluate the effectiveness of acupuncture and traditional moxibustion during HD for safety reasons (eg: risk of bleeding, burns and unpleasant smell). Therefore, the heating device appears to be a non-invasive and safe method for treating IDH. The investigators conduct a clinical trial using infrared heating devices without direct contact to the skin on low temperatures (56±8℃) in treating patients with IDH. 30 eligible participants diagnosed with IDH will be enrolled and divided into Group 1 and Group 2. Treatment 1# will be regular dialysis 3 times per week for 4 weeks. Treatment 2# will be regular dialysis 3 times per week plus "HEALTHY BOX" Powered heating pad on acupoint CV4 at the abdomen for 1 hour during dialysis, also for 4 weeks. For Group 1, each subject will receive Treatment 1# first, for Group 2, Treatment 2# will be received first. Then, it takes 2-week washout period with regular dialysis 3 times per week and make Group 1 and Group 2 crossover. Outcomes will include blood pressure changes, nursing intervention frequencies, IDH frequencies, the degree of cold intolerance, the degree of fatigue after dialysis and recovery time from fatigue after dialysis, the percentage of target ultrafiltration achieved and blood biochemistry. Data will be collected at the beginning of the study (baseline), end of Treatment 1 # , and end of Treatment 2#. Subjective questionnaires will be collected before and after each treatment period. The difference of evaluation scores between baseline and post-treatment will be analyzed using generalized linear mixed model. A value of P < 0.05 will be regarded as statistically significant for the above statistical analyses.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 30 eligible participants diagnosed with IDH will be enrolled and divided randomly and equally into Group 1 and Group 2 . Treatment 1# will be regular dialysis 3 times per week for 4 weeks. Treatment 2# will be regular dialysis 3 times per week plus "HEALTHY BOX" Powered heating pad on acupoint CV4 at the abdomen for 1 hour during dialysis, also for 4 weeks. For Group 1, each subject will receive Treatment 1# first, for Group 2, Treatment 2# will be received first. Then, a 2-week washout period with regular dialysis 3 times per week will be carried out. Group 1 will then receive Treatment 2# and Group 2 will then receive Treatment 1#. Subjective questionnaires will be done before and after each Treatment period.
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Device: "HEALTHY BOX" Powered heating pad (electronic moxibustion)For Group 1, each subject will receive Treatment 1# first. Then, it takes 2-week washout period with regular dialysis 3 times per week and then receive Treatment 2#. Treatment 1# will be regular dialysis 3 times per week for 4 weeks. Treatment 2# will be regular dialysis 3 times per week plus "HEALTHY BOX" Powered heating pad on acupoint CV4 at the abdomen for 1 hour during dialysis, also for 4 weeks. |
| Group 2 | Active comparator | Device: "HEALTHY BOX" Powered heating pad (electronic moxibustion)For Group 2, each subject will receive Treatment 2# first. Then, it takes 2-week washout period with regular dialysis 3 times per week and then receive Treatment 1#. Treatment 2# will be regular dialysis 3 times per week plus "HEALTHY BOX" Powered heating pad on acupoint CV4 at the abdomen for 1 hour during dialysis, also for 4 weeks. Treatment 1# will be regular dialysis 3 times per week for 4 weeks. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age between 20 to 80-years-old
- Willing to sign inform consent
- Weekly hemodialysis 3 times per week, each time at least 180 minutes
- During the past 2 months of hemodialysis, there is symptomatic intra-dialytic hypotension for over 15% of the time or under regular use of Midodrine.
Key exclusion criteria (5 listed)
- Pregnancy or breast-feeding
- Not able to fill out questionnaires
- Severe comorbidities, including cirrhosis, heart failure, autoimmune diseases and cancer
- Diabetic peripheral neuropathy or patients insensitive to heat or unable to effectively express themselves in heated situations
- Undergoing other types of alternative treatment, including Chinese medicine and regional remedies.
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 |
|---|---|---|
| "HEALTHY BOX" Powered heating pad (electronic moxibustion)Using heating pad (electronic moxibustion) with insulating materials on low temperatures (56±8℃) in treating patients with intra-dialytic hypotension | Device | Group 1, Group 2 |
Primary outcome
change of frequency of IDH episodes
Time frame: baseline, Treatment 1, Treatment 2
times of IDH episode according to NADIR, KDOQI criteria
change of number of nursing interventions during HD
Time frame: baseline, Treatment 1, Treatment 2
Trendelenburg position, man¬ual reduction of ultrafiltration rate, infusion of isotonic saline or hypertonic fluid, lowering of dialysate temperature
4 secondary outcomes
change of the degree of cold intolerance
Time frame: week 0,4,6,10
change of the degree of fatigue after dialysis
Time frame: before and after Treatment1 & 2
blood pressure changes
Time frame: baseline, Treatment 1, Treatment 2
change of recovery time from fatigue after dialysis
Time frame: before and after Treatment1 & 2
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 16 Sep 2021.
- Individual participant dataSharing planned: No. 1. There will be a research number representing the identity. This number will not display the name, ID number, and address. 2. For the results and diagnosis of the visit, the research host will maintain a confidential attitude and carefully maintain the privacy. If research results are published, the identity will remain confidential. 3. Please also understand that if the participant signs the consent form, the participant agrees that the visit record can be directly reviewed by the monitor, auditor, research ethics committee and the competent authority to ensure that the research process and data comply with relevant laws and regulations. These people also promise not to violate the confidentiality of your identity.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "HEALTHY BOX" Powered heating pad (electronic moxibustion) in people with Hemodialysis-Induced Symptom and Intra-dialytic Hypotension, run by Chang Gung Memorial Hospital at 1 site in 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 4 inclusion and 5 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 16 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
change of frequency of IDH episodes (time frame: baseline, Treatment 1, Treatment 2). The study lists 2 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 16 Sep 2021.