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Study protocol for a single-blind, placebo-controlled randomised trial of Tianjiu effects in patients with
Ming-Yen Tsai1, Yu-Jen Su2, Hwee-Yeong Ng2
1Graduate Institute of Integrated Medicine, College of Chinese Medicine, China Medical University, Taichung, Taiwan Department of Chinese Medicine, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung, Taiwan.
Insights
Intradialytic hypotension (IDH) during hemodialysis (HD) is common. Tianjiu therapy applied to specific acupoints may reduce IDH severity and improve patient outcomes in HD patients.
Area of Science:
- Nephrology
- Traditional Chinese Medicine
- Clinical Trials
Background:
- Intradialytic hypotension (IDH) is a frequent complication of hemodialysis (HD), associated with adverse cardiovascular events and increased mortality.
- The multifactorial etiology of IDH presents significant management challenges in HD patients.
Purpose of the Study:
- To investigate the efficacy of Tianjiu therapy in reducing the severity of IDH in patients undergoing HD.
- To evaluate Tianjiu's potential to influence hemodynamics and improve patient-reported outcomes during HD sessions.
Main Methods:
- A randomized controlled trial involving patients with IDH, divided into Tianjiu and control groups for 4 weeks.
- Tianjiu therapy applied to specific acupoints (conception vessel 4, bilateral kidney 1) in the treatment group; clay patches in the control group.
- Primary outcome: percentage of target ultrafiltration achieved. Secondary outcomes: IDH episode frequency, nursing interventions, blood pressure, and fatigue assessment.
Main Results:
- Pre-results from the trial will be used to determine the effectiveness and safety of Tianjiu therapy.
- Analysis will assess if Tianjiu offers a therapeutic effect beyond a placebo.
Conclusions:
- This study aims to provide evidence on the clinical utility of Tianjiu therapy for managing intradialytic hypotension.
- Findings will inform whether Tianjiu can be a safe and effective complementary treatment for HD patients experiencing IDH.
Introduction:
Intradialytic hypotension (IDH) is the most frequent complication of haemodialysis (HD) and may contribute to cardiovascular events and high mortality. The aetiology of IDH is multifactorial; therefore, it remains a challenging problem in the management of patients with HD. Since the application of Tianjiu at specific points can influence haemodynamics, we hypothesise that Tianjiu therapy at the traditionally used meridian points will reduce the severity of hypotension in patients who undergo HD.
Methods/Analysis:
In this clinical trial, eligible patients with IDH will be divided randomly and equally into a Tianjiu group and a control group for 4 weeks. In the Tianjiu group, the patients will have Tianjiu applied at three points (conception vessel 4, and bilateral kidney 1) during each HD session. In the control group, patients will have clay patches applied in the same way as those in the Tianjiu treatment group. Both groups will be followed up for 2 weeks. The primary outcome measure will be the percentage of target ultrafiltration achieved, defined as the actual ultrafiltration volume divided by the target ultrafiltration volume. Secondary outcome measures, including frequency of IDH episodes and number of nursing interventions during HD sessions, predialysis and postdialysis blood pressure (BP), patient's participative assessment of the degree of fatigue after dialysis (scale from 0, not at all, to 10, extremely), and recovery time from fatigue after dialysis will be recorded at the 0th and 4th weeks.
Ethics/Dissemination:
This trial has undergone ethical scrutiny and been approved by the ethics review board of Chang Gung Memorial Hospital (Permission number: 102-4749A3 and 104-3156C). The pre-results of this trial will help to determine whether Tianjiu is an effective and safe treatment for IDH, and, if so, whether it is a therapeutic effect rather than a placebo effect.
Trial Registration Number:
NCT02210377; Pre-results.
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