Clinical trial NCT03856151: To Evaluate the Effects of Heating Device (Electronic Moxibustion) in Patients With Intradialytic Hypotension
Official title: To Evaluate the Effects of Heating Device (Electronic Moxibustion) in Patients With Intradialytic Hypotension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemodialysis-Induced Symptom
Intra-dialytic Hypotension
Keywords: hemodialysis
Intra-dialytic Hypotension
heating device
electronic moxibustion
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2019-02-27
Enrollment: 32
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

1. Age between 20 to 80-years-old
2. Willing to sign inform consent
3. Weekly hemodialysis 3 times per week, each time at least 180 minutes
4. 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.

Exclusion Criteria:

1. Pregnancy or breast-feeding
2. Not able to fill out questionnaires
3. Severe comorbidities, including cirrhosis, heart failure, autoimmune diseases and cancer
4. Diabetic peripheral neuropathy or patients insensitive to heat or unable to effectively express themselves in heated situations
5. Undergoing other types of alternative treatment, including Chinese medicine and regional remedies.

Primary outcomes:
measure: change of frequency of IDH episodes
timeFrame: baseline, Treatment 1, Treatment 2
measure: change of number of nursing interventions during HD
timeFrame: baseline, Treatment 1, Treatment 2
Secondary outcomes:
measure: change of the degree of cold intolerance
timeFrame: week 0,4,6,10
measure: change of the degree of fatigue after dialysis
timeFrame: before and after Treatment1 & 2
measure: blood pressure changes
timeFrame: baseline, Treatment 1, Treatment 2
measure: change of recovery time from fatigue after dialysis
timeFrame: before and after Treatment1 & 2
Other outcomes:
Locations:
city: Keelung
country: Taiwan
facility: Keelung Chang Gung Memorial Hospital
Study officials:
References: