Radar-A: A Phase 2 Multi-center Study to Evaluate the Safety and Tolerability of Using Point-of-Care-Guided Manipulation of Dialysate Potassium and Dialysate Bicarbonate to Prevent Hemodialysis-Associated Arrhythmias
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Number of Participants Enrolled Per Month
研究概览
简要总结
The primary purpose of this study is to test the feasibility of trials which change the dialysate (dialysis bath prescription) of potassium and bicarbonate according to a standardized algorithm and according to the results of blood testing performed prior to each dialysis. In addition, the trial will provide estimates of the extent to which performing dialysis in this way lowers the risk of abnormal heart rhythms in people with kidney failure who are being treated with chronic hemodialysis.
详细描述
Within four weeks of consent, subjects will have an Implantable Loop Recorder (ILR) (Medtronic LINQ) device implanted. Subjects will be given a transmitter/charger and a Patient Care Assistant which they will be required to keep for the duration of their participation in the study. ILR tracings will be uploaded automatically and reviewed by the study team for the occurrence of clinically significant arrhythmia.
Following ILR implantation, subjects will have 1 month of standard dialysis and will crossover in random order between four month-long periods of dialysis guided by the results of the point of care testing. Whole blood will be obtained by dialysis staff and immediately tested on a point of care chemistry analyzer according to the manufacturer's protocol prior to each dialysis session. The randomized intervention periods will include algorithms that alter the potassium bath in order to a) maximize potassium removal or b) minimize potassium removal as well as a second set of algorithms that alter the bicarbonate bath in order to c) limit acidosis or d) limit alkalosis.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Maintenance hemodialysis therapy for end-stage renal disease
- •Age 18-85 years (subjects between 18-40 years old will be required to have at least one of the following: history of congestive failure, diabetes, coronary or peripheral vascular disease, or arrhythmia)
- •>30 days since dialysis initiation
- •Ability to provide informed consent
排除标准
- •Expected survival <6 monthsRenal transplant, transfer to home or peritoneal dialysis, or to non-study hemodialysis facility anticipated within 6 months
- •Prisoners or cognitive disability preventing informed consent
- •Pregnancy. A pregnancy test will be required for women of child bearing potential prior to enrollment. A pregnancy test will not be required for women past the age of child-bearing potential >55 years old, women with a history of surgical sterilization, or for women <55 years of age who have not had a menses within the past 12 months.
- •Skin condition, immune dysfunction, history of multiple infections or other condition which increases risk of local infection with ILR placement
- •Bleeding disorder or anti-coagulation that cannot be reversed for ILR placement
- •Existing pacemaker, implantable monitor or defibrillator which precludes device placement
- •Chronic, persistent AF. Defined as the presence of persistent AF on all available EKGs at time of recent screening.
- •Hemoglobin <8 g/dL-Serum K >6.5 or <3.5 mEq/L within 30 days
结局指标
主要结局
Number of Participants Enrolled Per Month
时间窗: Up to Week 24
Assessment of recruitment feasibility.
Proportion of Participants Who Experienced Potassium Intervention-Specific Complications
时间窗: Up to Week 24
Potassium Intervention-Specific Complications are defined as either severe potassium abnormalities (potassium ≥ 6.5 or ≤ 3.0 mEq/L) or unscheduled HD or hospitalization for hyper/hypokalemia in the absence of a missed treatment.
Proportion of Participants Who Experience Bicarbonate Intervention-Specific Complications
时间窗: Up to Week 24
Bicarbonate Intervention-Specific Complications are defined as severe HCO3 abnormalities (HCO3 \<20 or \>32 mEq/L) or unscheduled HD or hospitalization for acid base abnormalities in the absence of a missed treatment.
Mean Monthly Duration of Clinically Significant Arrhythmia (CSA)
时间窗: Up to Week 24
CSA will be defined on the basis of arrhythmias likely to lead to sudden cardiac arrest (SCA) or serious morbidity and mortality and will include AF, asystole ≥3 seconds, bradycardia ≤40 beats per minute lasting ≥6 seconds, and sustained VT ≥130 beats per minute lasting ≥30 seconds.
Adherence With Proposed Interventions
时间窗: Up to Week 24
Adherence will be assessed as the percent of sessions in which POC testing is completed and the dialysate is adjusted according to the algorithm.
次要结局
- Mean Duration of Atrial Fibrillation(Up to Week 24)
- Incidence of Potentially Lethal Arrhythmias(Up to Week 24)
- Percent of Sessions in Which POC-Guided Dialysate Prescription Differs From Standard of Care-Guided Prescription(Up to Week 24)
- Incidence of Hospitalization(Up to Week 24)
- Number of Screened Patients Who Are Enrolled(Up to Week 24)
- All-Cause Mortality(Up to Week 24)
- Cardiovascular Mortality(Up to Week 24)