Effects of L-carnitine Therapy on the Heart of Maintenance Hemodialysis Patients: A Multicenter, Prospective, Non-randomized, Controlled Real-world Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,008
- 试验地点
- 1
- 主要终点
- Change from baseline in Left ventricular ejection fraction
研究概览
简要总结
This study is intended to be a multicenter, prospective, non-randomized, controlled real-world study. Patients receiving L-carnitine injection were included in the experimental group and the control group according to whether they received L-carnitine injection. Patients receiving L-carnitine injection were included in the experimental group, and those receiving L-carnitine injection were included in the control group.To observe the effects of L-carnitine on cardiac function in hemodialysis patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Maintenance hemodialysis patients;
- •18 years<80 years;
- •Have clear consciousness and independent behavior ability;
- •Before dialysis, the total carnitine concentration was less than 40 umol/L, or the free carnitine concentration was less than 35 umol/L.
排除标准
- •Acute cardiovascular and cerebrovascular diseases occurred within 1 month;
- •Infectious diseases occurred within 1 month; Treatment with glucocorticoid or immunosuppressant;
- •Patients who have used L-carnitine within 2 weeks.
- •Hematological system tumor or tumor;
研究组 & 干预措施
Test group
The patients in the test group were injected with levocarnitine on each dialysis day, and other conventional treatment drugs such as hemodialysis drugs were maintained in the original scheme and recorded in detail on the CRF form.
干预措施: Levocarnitine Injection (Drug)
结局指标
主要结局
Change from baseline in Left ventricular ejection fraction
时间窗: baseline and week 12
次要结局
- Change from baseline in the ratio of peak E to peak A of mitral valve blood flow velocity in early and late diastolic periods(baseline and week 12)
- Change from baseline in stroke volume(baseline and week 12)
- Change from baseline in upper arm circumference(baseline and week 12)
- Change from baseline in Brain natriuretic peptide level(baseline ,week 4 and week 12)
- Change from baseline in prealbumin(baseline and week 12)
- Change from baseline in serum albumin(baseline and week 12)
- Change from baseline in left ventricular short axis shortening rate(baseline and week 12)
- Change from baseline in hemoglobin(baseline and week 12)