Early Administration of L-carnitine in Hemodialysis Patients: Double Blind Randomized Trial Versus Placebo
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Haemoglobin level/weekly rHuerythropoietin dose in patients receiving l-carnitine versus those receiving the placebo.
研究概览
简要总结
Hemodialysis is a cause of carnitine deficiency. The deficiency of carnitine induces an anemia by an increase fragility of the red blood cells, a muscular fatigue and a cardiac dysfunction. We proposed to evaluate the benefit of an early administration of L-carnitine in hemodialysis patients. The patients should be included in the first month after the start of chronic hemodialysis, randomized to receive L-carnitine or placebo and should be followed-up during one year.
详细描述
The first aim of the study is to compare the resistance index to erythropoietin (hemoglobin level / rHuerythropoietin dose) with L-carnitine versus placebo Double blind randomized study evaluating the supplementation with L-carnitine versus placebo in patients beginning chronic hemodialysis for less than 1 month.
Primary outcome to compare rHuerythropoietin resistance index defined as hemoglobin level / rHuEPO dose ratio with L-carnitine and with placebo.
Secondary endpoints to compare acylcarnitine / carnitine ratio, number of red blood cells transfusion, physical status, quality of life, hypotensive episodes, lipid profile, diabetes profile, albuminemia, c reactive protein.
Several variables that influenced primary and secondary endpoints will be included in a multivariate analysis; albuminemia, c reactive protein, iron status, dialysis efficiency, protein intake, lipid intake, treatment with additional vitamins (C, B9, B6), treatment with statins, treatment of predialysis hypotension by midodrine, antihypertensive treatments.
Statistical analysis:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Patient with less than 1 month on hemodialysis.
- •Treated with rHuEPO.
- •Male or female aged of more than 18 years old.
- •With contraception treatment for women of procreation age.
- •Having received and understand information.
排除标准
- •Patients with no need of rHuEPO
- •Patients with cancer disease
- •Patients with life expectancy under 6 months
- •Patients having a proved carnitine deficiency before the start of hemodialysis
研究组 & 干预措施
1
L-Carnitine
干预措施: L-Carnitine (Drug)
结局指标
主要结局
Haemoglobin level/weekly rHuerythropoietin dose in patients receiving l-carnitine versus those receiving the placebo.
时间窗: during the study
Haemoglobin level/weekly rHuerythropoietin dose in patients receiving l-carnitine versus those receiving the placebo.
Resistance index to erythropoietin
时间窗: during de study
Resistance index to erythropoietin
次要结局
- Acylcarnitine/carnitine ratio measured quarterly(during the study)
- Number of red blood cells transfusion per patient during the study, data collected monthly(during the study)
- Predialysis hypotension per patient during the study, data collected monthly(during the study)
- SF 36 physical and total score at inclusion and at the end of the study(during the study)
- Lipid profile, measured quarterly(during the study)
- HbA1c, measured quarterly for diabetic patients and patients with glucose intolerance(during the study)
- Albuminemia measured quarterly(during the study)
- c reactive protein measured quarterly(during the study)