A Phase 2 interventional study of Tianjiu and Placebo (non-Tianjiu) in Intradialytic Hypotension, sponsored by Chang Gung Memorial Hospital. Status unknown at 1 site in Taiwan. Open to participants aged 20 Years to 75 Years. Per ClinicalTrials.gov, last updated 2016-02-01.
Sponsored by Chang Gung Memorial Hospital · Phase 2, Interventional, and Treatment
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.
1,003 studies on the registry are indexed under Hypotension; 173 are open to participants now.
This study's planned enrollment of 45 is below the median of 80 across 675 interventional studies indexed under Hypotension.
Browse Hypotension studies →Chang Gung Memorial Hospital is the lead sponsor of 1,064 studies on the registry; 235 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
The participants in the control group will be given placebo patches (brown clay patches) on the same sites.
Other: Placebo (non-Tianjiu)
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
Also known as: auto-moxibustion, herbal acupoint paste
The format of the placebo (clay) intervention will be the same as in the treatment group.
The % of target ultrafiltration achieved
The actual ultrafiltration volume divided by the target ultrafiltration volume
Time frame: 1 year
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
Time frame: 1 year
patient's participative assessment of the degree of fatigue after dialysis (scale from 0-10)
The improvement of subjective symptom
Time frame: 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
Time frame: 1 year
Plan to share: Undecided — Depending on the progress to decide.
This study is status unknown, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.
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Chang Gung Memorial Hospital