Prospective Randomized Multicenter Study to Demonstrate the Benefits of Hemodialysis Without Acetate (With Citrate): ABC-treat Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 90
- 试验地点
- 24
- 主要终点
- Effect of citrate dialysate on acid base status in hemodialysis patients measured by pH, BEecf and Bicarbonate at the end of HD session.
研究概览
简要总结
Prospective randomized cross-over multicenter study to demonstrate the benefits of hemodialysis without acetate dialysate, with citrate.
32 weeks duration, in two phases. In the first, half of the patients started with citrate dialysate for 16 weeks and the other half with acetate dialysate, and then patients cross.
The primary objective is to analyze the effect of citrate dialysate on acid base balance decreasing chronic metabolic acidosis and avoiding / reducing post-dialytic alkalosis.
详细描述
Primary objective: to analyze the effect of citrate dialysate on acid base balance decreasing chronic metabolic acidosis and avoiding / reducing post-dialytic alkalosis.
Secondary objectives:
- Evaluate the effect of dialysate on the variation of calcium pre and post-dialytic, as well as on the parathormone (PTH)
- Assess the effect of dialysate on inflammation
- Assess the effect of dialysate on the Elimination of small and medium-sized molecules
- Assess the effect of dialysate on the tolerance to the hemodialysis sessions
- Assess the effect of dialysate on nutritional parameters
Patients: Adult patients dialysed three times per week for at least 3 months will be enrolled in 12 Spanish dialysis centres. Catheter as vascular access will be excluded.
Design: prospective randomized multicenter, cross-over trial of chronic haemodialysis patients to compare the effect of citrate dialysate with acetate dialysate.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Outpatient conventional hemodialysis three times per week for at least three months.
- •Arteriovenous fistula as vascular access
- •Patients who have given their informed consent in writing.
排除标准
- •Catheter as vascular access
- •Allergy or intolerance to citrate
- •Patients with sufficient cognitive impairment that would prevent the compression of information and informed consent.
- •Inflammatory intercurrent diseases (chronic infections, autoimmune diseases or tumors) that can mask the results of the study.
研究组 & 干预措施
Citrate dialysate
Hemodialysis with citrate dialysate during 16 weeks
干预措施: Citrate dialysate (Other)
Acetate dialysate
Hemodialysis with acetate dialysate during 16 weeks
结局指标
主要结局
Effect of citrate dialysate on acid base status in hemodialysis patients measured by pH, BEecf and Bicarbonate at the end of HD session.
时间窗: 32 weeks
The anion gap will be calculated as: Anion gap = \[Na+\] - (\[Cl-\] + \[CO3H-\])
次要结局
- Compare the effect of citrate dialysate with acetate dialysate on calcium level(32 weeks)
- Compare the effect of citrate dialysate with acetate dialysate on phosphate level(32 weeks)
- Compare the effect of citrate dialysate with acetate dialysate on parathormone level.(32 weeks)
- Inflammation status by blood determination of IL-6(32 weeks)
- Inflammation status by blood determination of us-PCR(32 weeks)
- Inflammation status by blood determination of ERI(32 weeks)
- Effect of citrate dialysate on the hemodialysis elimination of small and medium-sized in molecules using reduction ratio (RR) of Urea(32 weeks)
- Effect of citrate dialysate on the hemodialysis elimination of small and medium-sized in molecules using reduction ratio (RR) of Beta2-microglobulin(32 weeks)
- Effect of citrate dialysate on the tolerance to the hemodialysis sessions by determining number of intradyalitic hypotensions(32 weeks)
- Effect of citrate dialysate on the nutritional parameters measured by biological parameters(32 weeks)