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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03856151
Other study ID # 201801853A3
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 17, 2019
Est. completion date April 28, 2021

Study information

Verified date January 2019
Source Chang Gung Memorial Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study is to investigate the effects of heating device among otherwise stable patients with intradialytic hypotension


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.


Recruitment information / eligibility

Status Completed
Enrollment 32
Est. completion date April 28, 2021
Est. primary completion date April 20, 2020
Accepts healthy volunteers No
Gender All
Age group 20 Years to 80 Years
Eligibility 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.

Study Design


Intervention

Device:
"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

Locations

Country Name City State
Taiwan Keelung Chang Gung Memorial Hospital Keelung

Sponsors (1)

Lead Sponsor Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary change of frequency of IDH episodes times of IDH episode according to NADIR, KDOQI criteria baseline, Treatment 1, Treatment 2
Primary 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
Secondary change of the degree of cold intolerance from 0 to 100; 0 is not cold, 100 is very cold week 0,4,6,10
Secondary change of the degree of fatigue after dialysis scores from 0-10;0 is not tired, 10 is very tired before and after Treatment1 & 2
Secondary blood pressure changes systolic, diastolic blood pressure and mean arterial pressure: mmHg baseline, Treatment 1, Treatment 2
Secondary 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
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