The Efficacy and Safety of Guilu Erxian Jiao in the Treatment of Intradialytic Hypotension
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Frequency of Intradialytic Hypotension Episodes
研究概览
简要总结
The goal of this clinical trial is to learn if Guilu Erxian Jiao, a traditional Chinese herbal medicine, can help manage intradialytic hypotension (IDH), a drop in blood pressure that occurs during hemodialysis in adults. The main questions it aims to answer are:
- Does Guilu Erxian Jiao reduce the frequency and severity of low blood pressure during dialysis?
- Is Guilu Erxian Jiao safe to use in patients receiving hemodialysis?
Researchers will compare standard care plus Guilu ErXian Jiao to standard care alone to see if Guilu Erxian Jiao improves blood pressure stability during dialysis.
Participants will:
- Take Guilu Erxian Jiao once daily in addition to standard care, or receive standard care alone, for 4 weeks, then switch treatments after a 4-week washout period (crossover design).
- Undergo follow-up assessments at weeks 2 and 4 after each treatment phase.
- Have their blood pressure monitored before, during (hourly), and after each dialysis session.
- Report dialysis-related symptoms such as dizziness and fatigue.
- Receive routine laboratory tests and safety monitoring throughout the study.
详细描述
- Clinical Background and Study Rationale
Intradialytic hypotension (IDH) is defined as a decrease in systolic blood pressure of more than 20 mmHg or a drop of more than 10 mmHg in mean arterial pressure during hemodialysis, often accompanied by symptoms such as dizziness, nausea, or cramps. The incidence of IDH among dialysis patients is approximately 5% to 30%. Risk factors include advanced age, diabetes, female sex, and high body mass index. IDH can cause premature termination of dialysis sessions, resulting in decreased uremic toxin clearance and increased long-term mortality and complications. Severe IDH may lead to bowel ischemia, stroke, or myocardial infarction.
Common management strategies for IDH include adjusting the dialysis rate, lowering dialysate temperature, avoiding eating during dialysis, and strict sodium intake control. In cases of frequent IDH episodes, drugs such as Midodrine or Vasopressin may be used. However, oral Midodrine can cause side effects such as urinary retention, paresthesia, and pruritus. Its long-term safety in dialysis patients is yet to be confirmed.
According to Traditional Chinese Medicine (TCM), IDH results from spleen and kidney Qi deficiency, requiring tonification of these organs. Guilu Erxian Jiao (GLJ) is a classical formula composed of Testudinis Carapax, Cervi Cornu, Lycii Fructus, and Ginseng Radix, commonly used to treat Qi deficiency and hypotension. Clinical experience suggests potential efficacy in reducing IDH frequency, but large-scale trials are lacking.
This trial aims to evaluate the efficacy and safety of GLJ in treating IDH in patients undergoing hemodialysis. 2. Study Design and Methods
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Undergoing maintenance hemodialysis three times per week, 4 hours per session
- •History of intradialytic hypotension (IDH)
- •Willing and able to provide written informed consent
排除标准
- •Pregnant or lactating women
- •Severe comorbid illness, such as cancer, stroke, or liver cirrhosis
- •Inability to comply with study medication regimen
- •Regular use of antihypertensive medication
研究组 & 干预措施
Group A
Participants in Group A will receive Guilu Erxian Jiao (GLJ) plus usual care for 4 weeks, followed by a 4-week washout period, then 4 weeks of usual care alone.
干预措施: Guilu Erxian Jiao (Drug)
Group B
Participants in Group B will receive usual care alone for 4 weeks, followed by a 4-week washout period, then 4 weeks of Guilu Erxian Jiao (GLJ) plus usual care.
干预措施: Guilu Erxian Jiao (Drug)
结局指标
主要结局
Frequency of Intradialytic Hypotension Episodes
时间窗: From baseline through the entire 16-week crossover study, including each 4-week treatment phase and follow-up assessments conducted at 2 and 4 weeks after each treatment phase
Number of intradialytic hypotension (IDH) episodes, defined as a drop in systolic blood pressure \>20 mmHg or mean arterial pressure (MAP) \>10 mmHg, recorded during each dialysis session.
次要结局
- Change in Blood Pressure Before, During, and After Dialysis(From baseline through the entire 16-week crossover study, including each 4-week treatment phase and follow-up assessments conducted at 2 and 4 weeks after each treatment phase)
- Changes in Laboratory Parameters (Na, K, Ca, P, BUN, Cr)(At baseline and at week 4, 8, 12, and 16 of the study)
- Visual Analogue Scale (VAS) Scores for Dialysis-Related Clinical Symptoms(Assessments are conducted after each dialysis session throughout the 16-week crossover study, including each 4-week treatment phase and follow-up assessments at 2 and 4 weeks after each treatment phase, starting from baseline)
- Adverse Events Related to Guilu Erxian Jiao(Throughout the entire 16-week study period)
- Dialysis Nurse Interventions for IDH(During each dialysis session throughout the 16-week crossover study, including each 4-week treatment phase, and follow-up assessments conducted at 2 and 4 weeks after each treatment phase)