To Evaluate the Effects of Heating Device (Electronic Moxibustion) in Patients With Intradialytic Hypotension

NCT ID: NCT03856151

Last Updated: 2021-09-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-17
• Study Completion Date: 2021-04-28

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.

Conditions

Hemodialysis-Induced Symptom; Intra-dialytic Hypotension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Group 1

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 Type: ACTIVE_COMPARATOR

"HEALTHY BOX" Powered heating pad (electronic moxibustion)

Intervention Type: DEVICE

Using heating pad (electronic moxibustion) with insulating materials on low temperatures (56±8℃) in treating patients with intra-dialytic hypotension

Group 2

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.

Group Type: ACTIVE_COMPARATOR

"HEALTHY BOX" Powered heating pad (electronic moxibustion)

Intervention Type: DEVICE

Using heating pad (electronic moxibustion) with insulating materials on low temperatures (56±8℃) in treating patients with intra-dialytic hypotension

Interventions

"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

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chang Gung Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Keelung Chang Gung Memorial Hospital

Keelung, , Taiwan

Countries

Taiwan

Other Identifiers

201801853A3

Identifier Type: -

Identifier Source: org_study_id