A Preliminary Randomized Study of Tianjiu (Auto-moxibustion) Effects in Patients With Intradialytic Hypotension

Study Overview
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Brief Summary
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Intradialytic hypotension (IDH) is a most frequent complication of hemodialysis (HD) and may contribute to cardiovascular events and high mortality. The etiology of IDH is multifactorial; therefore, it remains a challenging problem in the management of HD patients. Because moxibustion (MO) at specific points can influences hemodynamics, we hypothesize that Tianjiu (auto-MO) at the traditionally used meridian points will reduce the severity of hypotension in patients who undergo HD.

Detailed Description
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In this clinical trial, 45 patients had IDH were divided randomly into two (auto-MO therapy and control) groups for 4 weeks. In the Tianjiu (auto-MO) group, the patients were applied at 3 points (Conception Vessel 4, and Kidney 1) for 3-4 h during HD sessions. All number of episodes complicated by symptomatic IDH during HD sessions and the number of IDH-related nursing interventions (Trendelenburg position, manual reduction of ultrafiltration rate, infusion of isotonic saline or hypertonic fluid, lowering of dialysate temperature) in a session were recorded. Pre- and post-dialysis systolic and diastolic BP, pre- and post-dialysis body weights, interdialytic weight gain, percentage of target ultrafiltration achieved, patient's subjective assessment of the degree of fatigue after dialysis (scale from 0 to 10; 0, not at all, 10, extremely) and recovery time from fatigue after dialysis were measured at the 0, 2nd, 4th and 6th week.

Official Title
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Department of Traditional Chinese Medicine, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung

Conditions
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Intradialytic Hypotension

Intervention / Treatment
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* Other: Tianjiu
* Other: Placebo (non-Tianjiu)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The subjects enrolled in the study were patients undergo regular hemodialysis, ranging from 20-75 years of age, at nephrologic clinic in KCGMH. These patients have experienced > 3 episodes of intradialytic hypotension in recent two months. Exclusion Criteria: (1)confounding diseases such as sepsis, cancer, decompensated liver cirrhosis, respiratory failure, and heart failure(NYHA>3), (2) disturbed consciousness, (3) pregnancy, (4) can't tolerate the heat and allergy to automoxibustion,

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tianjiu (auto-moxibustion)<br>The participants in the Tianjiu group will be treated with Chinese herbal patches at acupoints on the abdomen and plantar, three times per week, for 4 hours each time during HD. | Other: Tianjiu<br>* After randomization, patients in Tianjiu and placebo (non-Tianjiu) groups will receive 12 sessions of treatment over a 4-week treatment period.The format of the Tianjiu intervention will be the same as in the treatment group. Participants will be instructed to lie supine before their HD session, and then the bilateral KI1 and CV4<br>* Other names: auto-moxibustion, herbal acupoint paste;|
| Placebo Comparator: Non-Tianjiu (Non auto-MO)<br>The participants in the control group will be given placebo patches (brown clay patches) on the same sites. | Other: Placebo (non-Tianjiu)<br>* The format of the placebo (clay) intervention will be the same as in the treatment group.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The % of target ultrafiltration achieved | The actual ultrafiltration volume divided by the target ultrafiltration volume | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The frequency of IDH episodes and number of nursing interventions during HD sessions | The number of IDH record and related nursing intervention during each H/D session | 1 year | 
| patient's participative assessment of the degree of fatigue after dialysis (scale from 0-10) | The improvement of subjective symptom | 1 year | 
| Patients' recovery time from fatigue after dialysis | Recovery time is recorded within minutes, when arriving home, at bed time, the next morning, by next HD | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Auto-moxibusition, intra-dialytic hypotension, hemodialysis