Effect of Varied Dialysate Bicarbonate Levels on Phosphate and Potassium Removal: A Pilot Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Phosphate/Potassium Removal
研究概览
简要总结
Modeling of bicarbonate within the dialysate fluid, specifically a lower than standard concentration has been suggested in facilitating the removal of phosphate and potassium. To test this hypothesis, the study will use a cross-over study design to evaluate phosphate and potassium removal during dialysis by altering bicarbonate concentration in dialysis fluid (i.e. high bicarbonate, standard bicarbonate washout, low bicarbonate), and compare the effects of the different dialysate bicarbonate concentrations on the removal of phosphate and potassium during hemodialysis
详细描述
Elevation of blood phosphate levels in chronic dialysis patients is associated with increased mortality due to cardiovascular events, and if sustained leads to hyperactivity of parathyroid glands and renal bone disease. Similarly, increased calcium-phosphate product as a result of elevated levels of phosphate in the blood is an additional risk factor for vascular calcification. Elevated blood potassium levels is another major electrolyte disorder in patients with advanced renal disease which is potentially life threatening. Therefore control of blood phosphate and potassium levels is a fundamental component of treatment for end stage renal disease. Management of hyperelectrolyte levels in renal failure patients requires restriction of phosphate and potassium intake through dietary measures, promotion of excretion via GI tract through medication delivery (i.e. supplementary binders), and removal through dialysis. All these strategies come with limitations however, specifically adherence to dietary restrictions and medication compliance is poor due to lack of immediate repercussions, as well as the complex kinetics involved with removal via dialysis given the dependence on duration and frequency of dialysis whose manipulation is limited by time considerations for the patient and scheduling issues in the dialysis unit.
研究设计
- 研究类型
- Interventional
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 0-18 years old
- •Patients receiving maintenance hemodialysis* for a total of 9-15 hours per week
- •Pre-dialysis serum potassium value between 4.0 and 6.5 mmol/L on the first day of the treatment protocol
- •Pre-dialysis serum phosphate value greater than low normal for age on the first day of the treatment protocol
- •Pre-dialysis serum bicarbonate (total CO2) value between 18 and 30 mmol/L on the first day of the treatment protocol
- •Pre-dialysis corrected calcium value between 1.80-2.85 mmol/L on the first day of the treatment protocol
排除标准
- •Hemodynamically unstable patients (requiring inotropes or midodrine for support).
- •Pre-dialysis potassium value < 4.0 or > 6.5 mmol/L on the first day of the treatment protocol
- •Pre-dialysis serum phosphate value less than low normal for age on the first day of the treatment protocol (i.e. hypophosphatemia)
- •Pre-dialysis serum bicarbonate (total CO2) value <18 or > 30 mmol/L on the first day of the treatment protocol
- •Pre-dialysis corrected calcium <1.8 and >2.85 mmol/L on the first day of the treatment protocol
- •Patients mechanically ventilated
- •Drugs that could modify internal phosphate and potassium balance such as insulin, bicarbonate injection, hypertonic dextrose solution or mannitol infusion during HD
研究组 & 干预措施
Hemodialysis patients
Each patient will be evaluated during a total of 3.5 weeks correlating to routine dialysis treatment appointments. Each participant will start with low bicarbonate, followed by the washout phase (standard bicarbonate), then high bicarbonate, finishing with the follow up period. Dialysis prescription is standardized for each patient throughout the entire 3.5 week study period.
干预措施: Bicarbonate hemodialysis solution (low concentration) (Drug)
Hemodialysis patients
Each patient will be evaluated during a total of 3.5 weeks correlating to routine dialysis treatment appointments. Each participant will start with low bicarbonate, followed by the washout phase (standard bicarbonate), then high bicarbonate, finishing with the follow up period. Dialysis prescription is standardized for each patient throughout the entire 3.5 week study period.
干预措施: Bicarbonate hemodialysis solution (high concentration) (Drug)
结局指标
主要结局
Phosphate/Potassium Removal
时间窗: Dialysis Treatment 9 (Day 17) - Pre and Post dialysis (0hrs, 4hours, 5hours)
The amount of phosphate/potassium removed with each dialysis as measured from dialysate aliquots and total calculated volume of dialysate. The following formula will be used to calculate Phosphate (PO4) and Potassium (K) mass removal (mmol/treatment): Calculation based on the concentration of K/PO4 (mmol/L) in dialysate x (calculated volume of dialysate + calculated volume of ultrafiltrate)
次要结局
- Dialysis Adequacy (Urea Reduction Ratio -URR)(Pre and Post Dialysis (0 and 4hours))
- Plasma Phosphate Levels(Baseline and Post Dialysis (4hours))
- Plasma Potassium Levels(Pre and Post Dialysis)
- Total Plasma CO2 (bicarbonate)(Pre and Post Dialysis (0 and 4hours))
- Corrected Calcium Measurement(Pre and Post Dialysis (0 and 4hours))
- Dialysis Adequacy (Kt/ V)(Pre and Post Dialysis (0 and 4hours))
研究者
Elizabeth Harvey
Project Investigator
The Hospital for Sick Children