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

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

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02210377
Enrollment
45
Registered
2014-08-06
Start date
2015-03-31
Completion date
2016-06-30
Last updated
2016-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intradialytic Hypotension

Keywords

Auto-moxibusition, intra-dialytic hypotension, hemodialysis

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.

Interventions

OTHERTianjiu

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

OTHERPlacebo (non-Tianjiu)

The format of the placebo (clay) intervention will be the same as in the treatment group.

Sponsors

Chang Gung Memorial Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No

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,

Design outcomes

Primary

MeasureTime frameDescription
The % of target ultrafiltration achieved1 yearThe actual ultrafiltration volume divided by the target ultrafiltration volume

Secondary

MeasureTime frameDescription
The frequency of IDH episodes and number of nursing interventions during HD sessions1 yearThe 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 yearThe improvement of subjective symptom
Patients' recovery time from fatigue after dialysis1 yearRecovery time is recorded within minutes, when arriving home, at bed time, the next morning, by next HD

Countries

Taiwan

Contacts

Primary ContactMing-Yen Tsai, MS
missuriae@yahoo.com.tw

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026