Adding Urea to the Final Dialysis Fluid in Order to Prevent Dialysis Disequilibrium in Patients Who Need Aggressive Dialysis for Electrolyte Abnormalities
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Disequilibrium
研究概览
简要总结
At times patients with advanced renal failure present with severe hyperkalemia or acidosis and very high serum blood urea nitrogen (BUN) concentrations. These patients cannot be dialyzed aggressively as the lowering of serum BUN may results in disequilibrium syndrome but on the other hand they need aggressive dialysis in order to lower their serum potassium or fix their severe acidosis. If one is able to add urea to the dialysis fluid, one can prevent the rapid lowering of serum BUN and osmolality at the same time as doing aggressive dialysis to lower serum potassium and/or fix the metabolic acidosis.
详细描述
Ure-Na 15 gram tablets would be used to add to the dialysis fluid How much urea to add would be a simple calculation based on the 45X dialysis system and the patients serum urea concentration. The dialysate fluid urea concentration would be made to be about 15-40 mg/dL lower than the serum concentration. The patients labs/vitals and symptoms would be closely monitored throughout the dialysis treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Serum Urea > 120
- •Serum Potassium > 5.5 or serum CO2 < 15 or need for aggressive dialysis due to toxic ingestion
- •need for dialysis
排除标准
- •Pediatric
- •need for CRRT
研究组 & 干预措施
Urea dialysate
Patients who had urea added to the final dialysis fluid
干预措施: Urea in the dialysate (Drug)
结局指标
主要结局
Disequilibrium
时间窗: within 24 hours after starting dialysis
Dialysis disequilibrium syndrome (DDS) refers to an array of neurological manifestations that are seen during or following dialysis. The symptoms can range from headache, nausea, blurred vision, restlessness and confusion to coma and seizures in rare cases. The physician will assess DDS.
Serum potassium concentration
时间窗: Potassium levels every 6 hours for 24 hours after end of dialysis
Improvement in serum potassium concentration in mEq/L would be measured and documented with the study
Serum CO2 concentration
时间窗: Serum CO2 levels every 6 hours for 24 hours after end of dialysis
Improvement in metabolic acidosis would be monitored by checking serum CO2 concentration in mEq/L
次要结局
- Serum BUN concentration(Serum BUN concentration twice a day for 3 days)