Department of Traditional Chinese Medicine, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Intradialytic Hypotension
- Sponsor
- Chang Gung Memorial Hospital
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- The % of target ultrafiltration achieved
- Last Updated
- 10 years ago
Overview
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.
Investigators
Ming-Yen Tsai
Department of TCM
Chang Gung Memorial Hospital
Eligibility Criteria
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,
Outcomes
Primary Outcomes
The % of target ultrafiltration achieved
Time Frame: 1 year
The actual ultrafiltration volume divided by the target ultrafiltration volume
Secondary Outcomes
- The frequency of IDH episodes and number of nursing interventions during HD sessions(1 year)
- patient's participative assessment of the degree of fatigue after dialysis (scale from 0-10)(1 year)
- Patients' recovery time from fatigue after dialysis(1 year)