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

NCT03856151 | Completed

• 1 other identifier: 201801853A3
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hemodialysis-Induced Symptom; Intra-dialytic Hypotension

Keywords

hemodialysis; Intra-dialytic Hypotension; heating device; electronic moxibustion

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• change of the degree of cold intolerance

  week 0,4,6,10

• change of the degree of fatigue after dialysis

  before and after Treatment1 & 2

• blood pressure changes

  baseline, Treatment 1, Treatment 2

• change of recovery time from fatigue after dialysis

  before and after Treatment1 & 2

Study Arms (2)

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.

Device: "HEALTHY BOX" Powered heating pad (electronic moxibustion)

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.

Device: "HEALTHY BOX" Powered heating pad (electronic moxibustion)

Interventions

"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

Group 1; Group 2

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 20 to 80-years-old
• Willing to sign inform consent
• Weekly hemodialysis 3 times per week, each time at least 180 minutes
• 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.

You may not qualify if:

• Pregnancy or breast-feeding
• Not able to fill out questionnaires
• Severe comorbidities, including cirrhosis, heart failure, autoimmune diseases and cancer
• Diabetic peripheral neuropathy or patients insensitive to heat or unable to effectively express themselves in heated situations
• Undergoing other types of alternative treatment, including Chinese medicine and regional remedies.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Keelung Chang Gung Memorial Hospital

Keelung, 20401, Taiwan

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 11, 2019
• First Posted: February 27, 2019
• Study Start: April 17, 2019
• Primary Completion: April 20, 2020
• Study Completion: April 28, 2021
• Last Updated: September 16, 2021

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)