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

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

Study Overview

• Status: Completed
• Conditions: Hemodialysis-Induced Symptom; Intra-dialytic Hypotension
• Intervention / Treatment: Device: "HEALTHY BOX" Powered heating pad (electronic moxibustion)

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.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Keelung, Taiwan, 20401
    • Keelung Chang Gung Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	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
Active Comparator: 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.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 17, 2019
• Primary Completion (Actual): April 20, 2020
• Study Completion (Actual): April 28, 2021

Study Registration Dates

• First Submitted: February 11, 2019
• First Submitted That Met QC Criteria: February 25, 2019
• First Posted (Actual): February 27, 2019

Study Record Updates

• Last Update Posted (Actual): September 16, 2021
• Last Update Submitted That Met QC Criteria: September 10, 2021
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: hemodialysis; heating device; Intra-dialytic Hypotension; electronic moxibustion
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypotension
• Other Study ID Numbers: 201801853A3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There will be a research number representing the identity. This number will not display the name, ID number, and address.; For the results and diagnosis of the visit, the research host will maintain a confidential attitude and carefully maintain the privacy. If research results are published, the identity will remain confidential.; Please also understand that if the participant signs the consent form, the participant agrees that the visit record can be directly reviewed by the monitor, auditor, research ethics committee and the competent authority to ensure that the research process and data comply with relevant laws and regulations. These people also promise not to violate the confidentiality of your identity.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No