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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tianjiu (auto-moxibustion) | Experimental | 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. |
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| Non-Tianjiu (Non auto-MO) | Placebo Comparator | The participants in the control group will be given placebo patches (brown clay patches) on the same sites. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tianjiu | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The % of target ultrafiltration achieved | The actual ultrafiltration volume divided by the target ultrafiltration volume | 1 year |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ming-Yen Tsai, MS | Contact | missuriae@yahoo.com.tw |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaohsiung Chang Gung Memorial Hospital | Recruiting | Kaohsiung City | 83301 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37651553 | Derived | Natale P, Ju A, Strippoli GF, Craig JC, Saglimbene VM, Unruh ML, Stallone G, Jaure A. Interventions for fatigue in people with kidney failure requiring dialysis. Cochrane Database Syst Rev. 2023 Aug 31;8(8):CD013074. doi: 10.1002/14651858.CD013074.pub2. | |
| 26966058 | Derived | Tsai MY, Su YJ, Ng HY, Chen SY, Huang YC, Wu CH, Chen YH. Study protocol for a single-blind, placebo-controlled randomised trial of Tianjiu effects in patients with intradialytic hypotension. BMJ Open. 2016 Mar 10;6(3):e009976. doi: 10.1136/bmjopen-2015-009976. |
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Depending on the progress to decide.
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|
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| Placebo (non-Tianjiu) | Other | The format of the placebo (clay) intervention will be the same as in the treatment group. |
|
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 |