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.