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The aim of this study is to investigate the effects of heating device among otherwise stable patients with intradialytic hypotension
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| "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 |
| Measure | Description | Time Frame |
|---|---|---|
| change of frequency of IDH episodes | times of IDH episode according to NADIR, KDOQI criteria | 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 | baseline, Treatment 1, Treatment 2 |
| Measure | Description | Time Frame |
|---|---|---|
| change of the degree of cold intolerance | from 0 to 100; 0 is not cold, 100 is very cold | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Keelung Chang Gung Memorial Hospital | Keelung | 20401 | Taiwan |
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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.
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| before and after Treatment1 & 2 |
| blood pressure changes | systolic, diastolic blood pressure and mean arterial pressure: mmHg | 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) | before and after Treatment1 & 2 |