The Reducing Adverse Outcomes in Dialysis by Adjusting the pRescription for Dialysate Potassium Trial (RADAR-K): A Randomized, Controlled, Pilot Trial Comparing Usual Care to a Precision Approach to Dialysis Potassium Prescribing.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 120
- 主要终点
- Intervention Adherence
研究概览
简要总结
This will be a randomized controlled pilot trial comparing usual care to a precision approach to dialysis potassium prescribing. The precision approach will incorporate point of care testing of blood potassium concentration prior to each dialysis session and adjustment of the dialysate K prescription with a blood-dialysate K gradient minimization strategy (PKRxHD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Undergoing in-center, 3x/weekly HD for treatment of end-stage kidney disease (ESKD) for at least 90 days
- •Age at least 21 years
- •Prescribed HD time up to 15 hours/ week
排除标准
- •Incarcerated
- •Life expectancy of 1 year or less
- •Kidney transplant, transition to home dialysis, or transfer to non-participating HD unit anticipated within 6 months or less
- •Cognitive condition that precludes consent
- •Severe anemia (hemoglobin < 8.0 g/dL) within 30 days
- •K concentration of 7.0 mEq/L or more within 60 days
- •Pregnant women
- •Women of childbearing potential actively trying to conceive unwilling to use contraception
- •Participation in other interventional studies within 30 days prior to enrollment
研究组 & 干预措施
Precision approach to K Prescription for HD (PKRxHD)
Participants will receive a novel dialysate potassium (K) management strategy.
干预措施: PKRxHD (Other)
Usual Care
Standard dialysis potassium prescribing.
干预措施: Dialysis (Procedure)
Precision approach to K Prescription for HD (PKRxHD)
Participants will receive a novel dialysate potassium (K) management strategy.
干预措施: Dialysis (Procedure)
结局指标
主要结局
Intervention Adherence
时间窗: Up to Week 24
Measured as the proportion of hemodialysis (HD) treatments in the experimental arm completed per protocol with both pre-HD point of care testing and appropriate adjustment of the dialysate prescription.
Recruitment Feasibility
时间窗: Baseline
Measured as the proportion of eligible patients enrolled successfully.
Incidence Rate of Pre-HD Hyperkalemia
时间窗: Baseline
Hyperkalemia is defined as K≥ 6.4 mEq/L.
Post-HD Recovery Time
时间窗: Up to Week 24
Measured as the average time to recovery following each HD session.
次要结局
- Incidence Rate of Post-HD Hyperkalemia Incidence Rate(Up to Week 24)
- Incidence Rate of Moderate Hyperkalemia(Up to Week 24)
- Incidence Rate of Peri-Dialytic Cramping(Up to Week 24)
- Incidence Rate of Intradialytic Hypotension(Up to Week 24)