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

Phase 2

• Conditions: Intradialytic Hypotension
• Interventions: Other: Tianjiu; Other: Placebo (non-Tianjiu)

• Registration Number: NCT02210377
• Lead Sponsor: Chang Gung Memorial Hospital

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2014-08-03
• Study First Submitted QC: 2014-08-04
• Study First Posted: 2014-08-06
• Study Start: 2015-03
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-28
• Last Update Posted: 2016-02-01
• Primary Completion: 2016-06
• Study Completion: 2016-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 45

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,

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tianjiu (auto-moxibustion)	Tianjiu	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.
Non-Tianjiu (Non auto-MO)	Placebo (non-Tianjiu)	The participants in the control group will be given placebo patches (brown clay patches) on the same sites.

Primary Outcome Measures

Name	Time	Method
The % of target ultrafiltration achieved	1 year	The actual ultrafiltration volume divided by the target ultrafiltration volume

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Kaohsiung Chang Gung Memorial Hospital; 🇨🇳 Kaohsiung, Taiwan