Effect of Modifying Magnesium Concentration in Citrate-enriched Dialysate on Serum Magnesium Levels: a Randomized Single-blind Crossover Study: Pilot-OMAGOD
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 4
- 主要终点
- Proportion predialysis magnesium in target range
研究概览
简要总结
Individuals with ESKD and treated with hemodialysis have a high mortality risk. Associative studies suggest a relationship between serum magnesium concentration and mortality risk. The influence of magnesium concentration on mortality risk is unknown. This pilot study will explore whether altering dialysate magnesium concentration in the presence of citrate will change serum magnesium concentrations.
详细描述
To determine if a citrate enriched, Mg 1.0 mmol/L dialysate, when compared to a Mg 0,75 mmol/L citrate enriched dialysate leads to a:
- higher average serum predialysis total Mg on day 15 of the intervention
- higher average serum predialysis ionized Mg on day 15 of the intervention
- higher average serum postdialysis ionized Mg on day 15 of the intervention
- smaller proportion of patients with serum predialysis Mg <1,05 mmol/L on day 15 of the intervention
- larger proportion of patients with serum predialysis Mg > 1,50 mmol/L on day 15 of the intervention
- larger difference in predialysis Mg on day 15 versus day one of the intervention.
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
- Single (Participant)
盲法说明
Participant-blinded, open to care providers and investigators
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
- •Written informed consent must be obtained prior to any screening procedures
- •Clinically stable during two months prior to the study. This will be based upon clinical judgement.
- •On stable blood pressure medication 4 weeks prior to the study
- •Dialysis with a K3 dialysate
- •Adequate double-needle dialysis access (fistula or catheter)
- •Able to fill questionnaire/symptom score
排除标准
- •Predialysis calcium <1,9mmol/L during baseline
- •Magnesium predialysis >1,45mmol/L during baseline
- •Patient has a history of child C liver cirrhosis
- •Coronary intervention <3 months before randomization
- •Hospitalization <2 months before randomization
- •Uncontrolled predialysis hypertension >160/90mmHg despite 4 antihypertensive drugs
- •Predialysis blood pressure <90mmHg during baseline visit
- •History of dialysis access related problems <1 month before the randomization
- •Chronic Atrial fibrillation
- •NYHA class 4 heart failure
- •Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the CIP.
研究组 & 干预措施
Arm A - B
Patients undergo treatment with intervention A (dialysate magnesium 0.75 mmol), followed by intervention B (dialysate magnesium 1.00 mmol/l)
干预措施: A - Dialysate magnesium 0.75 (Device)
Arm A - B
Patients undergo treatment with intervention A (dialysate magnesium 0.75 mmol), followed by intervention B (dialysate magnesium 1.00 mmol/l)
干预措施: B - Dialysate magnesium 1.00 mmol/L (Device)
Arm B - A
Patients undergo treatment with intervention B (dialysate magnesium 1.00 mmol), followed by intervention A (dialysate magnesium 0.75 mmol/l)
干预措施: A - Dialysate magnesium 0.75 (Device)
Arm B - A
Patients undergo treatment with intervention B (dialysate magnesium 1.00 mmol), followed by intervention A (dialysate magnesium 0.75 mmol/l)
干预措施: B - Dialysate magnesium 1.00 mmol/L (Device)
结局指标
主要结局
Proportion predialysis magnesium in target range
时间窗: 2 weeks
Proportion of patients with a predialysis serum Mg concentration between 1,10 and 1,45mmol/L on day 15 of the intervention
次要结局
- Mean predialysis Magnesium(2 weeks)
- Mean predialysis ionized Magnesium(2 weeks)
- Mean postdialysis ionized Magnesium(2 weeks)
- Proportion low predialysis magnesium(2 weeks)
- Proportion high predialysis magnesium(2 weeks)
- Cardiac safety endpoint 1(2 weeks)
- Cardiac safety endpoint 2(2 weeks)