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To Evaluate the Effects of Heating Device in Patients With Intradialytic Hypotension

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03856151
Recruitment Status : Recruiting
First Posted : February 27, 2019
Last Update Posted : October 31, 2019
Sponsor:
Information provided by (Responsible Party):
Chang Gung Memorial Hospital

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

Condition or disease Intervention/treatment Phase
Hemodialysis-Induced Symptom Intra-dialytic Hypotension Device: "HEALTHY BOX" Powered heating pad Not Applicable

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 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 Early heating Group and Late heating Group. 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 Early heating Group, each subject will receive Treatment 1# first, for Late heating Group, Treatment 2# will be received first. Then, it takes 2-week washout period with regular dialysis 3 times per week and make Early heating Group and Late heating Group crossover. Primary outcomes will include blood pressure changes, the degree of cold intolerance, the degree of fatigue after dialysis and recovery time from fatigue after dialysis, cardiothoracic ratio, dose of midodrine used, the percentage of target ultrafiltration achieved and blood biochemistry. All the above data will be collected at the beginning of the study (baseline), end of Treatment 1 # , and end of Treatment 2#. The difference of evaluation scores between baseline and post-treatment will be analyzed using paired - T test. A value of P < 0.05 will be regarded as statistically significant for the above statistical analyses.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: 30 eligible participants diagnosed with IDH will be enrolled and divided randomly and equally into Early heating Group and Late heating Group. 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 Early heating Group, each subject will receive Treatment 1# first, for Late heating Group, Treatment 2# will be received first. Then, it takes 2-week washout period with regular dialysis 3 times per week and makeEarly heating Group and Late heating Group crossover.
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: To Evaluate the Effects of Heating Device in Patients With Intradialytic Hypotension
Actual Study Start Date : April 17, 2019
Estimated Primary Completion Date : October 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Early heating Group

For Early heating Group, each subject will receive Treatment 1# first. Then, it takes 2-week washout period with regular dialysis 3 times per week and do 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
Using heating device without direct contact to the skin (a piece of cork wood pad placed between skin and heating device) on low temperatures (56±8℃) in treating patients with intra-dialytic hypotension

Active Comparator: Late heating Group

For Late heating Group, each subject will receive Treatment 2# first. Then, it takes 2-week washout period with regular dialysis 3 times per week and do 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
Using heating device without direct contact to the skin (a piece of cork wood pad placed between skin and heating device) on low temperatures (56±8℃) in treating patients with intra-dialytic hypotension




Primary Outcome Measures :
  1. blood pressure changes [ Time Frame: through study completion: 10 weeks ]
    systolic and diastolic blood pressure: mmHg


Secondary Outcome Measures :
  1. the degree of cold intolerance [ Time Frame: before study, after 4 weeks, after 6 weeks, after 10 weeks ]
    from 0 to 100; 0 is not cold, 100 is very cold

  2. the degree of fatigue after dialysis [ Time Frame: before study, after 4 weeks, after 6 weeks, after 10 weeks ]
    scores from 0-10;0 is not tired, 10 is very tired

  3. cardiothoracic ratio (CTR) [ Time Frame: before treatment and after 10 weeks treatment ]
  4. dose of midodrine used [ Time Frame: before treatment and after 10 weeks treatment ]
  5. the percentage of target ultrafiltration achieved [ Time Frame: before treatment, after 4 weeks, after 6 weeks, after 10 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03856151


Contacts
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Contact: YUAN-CHIEH YEH, Doctor 24313131 ext 2127 b9005030@gmail.com
Contact: TAI-JAN LIU, Doctor 24313131 ext 2127 sarah78912@hotmail.com

Locations
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Taiwan
Keelung Chang Gung Memorial Hospital Recruiting
Keelung, Taiwan, 20401
Contact: YUAN-CHIEH YEH, Doctor    (02) 24313131 ext 2127    b9005030@gmail.com   
Contact: TAI-JAN LIU, Doctor    (02) 24313131 ext 2127    sarah78912@hotmail.com   
Sponsors and Collaborators
Chang Gung Memorial Hospital

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Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT03856151    
Other Study ID Numbers: 201801853A3
First Posted: February 27, 2019    Key Record Dates
Last Update Posted: October 31, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description:
  1. There will be a research number representing the identity. This number will not display the name, ID number, and address.
  2. 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.
  3. 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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Chang Gung Memorial Hospital:
hemodialysis
Intra-dialytic Hypotension
heating device
Additional relevant MeSH terms:
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Hypotension
Vascular Diseases
Cardiovascular Diseases