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

Chang Gung Medical Foundation

Status and phase: Unknown; Phase 2

Conditions: Intradialytic Hypotension

Treatments: Other: Placebo (non-Tianjiu); Other: Tianjiu

Study type: Interventional

Funder types: Other

Identifiers

NCT02210377

Chang Gung IRB 102-4749A3

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 45 estimated patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

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,

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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45 participants in 2 patient groups, including a placebo group

Tianjiu (auto-moxibustion)

Experimental group

Description:

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.

Treatment:

Other: Tianjiu

Non-Tianjiu (Non auto-MO)

Placebo Comparator group

Description:

The participants in the control group will be given placebo patches (brown clay patches) on the same sites.

Treatment:

Other: Placebo (non-Tianjiu)