Randomized trials using point of care-guided manipulation of dialysate potassium, dialysate bicarbonate, and ultrafiltration rate to prevent hemodilaysis-associated arrythmia

使用护理点指导控制透析液钾、透析液碳酸氢盐和超滤率来预防血液透析相关心律失常的随机试验

• 批准号: 9815883
• 负责人: David M Charytan
• 金额: $ 36.72万
• 依托单位: NEW YORK UNIVERSITY SCHOOL OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-03-01 至 2022-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9815883
• 关键词: Accounting; Acidosis; Acids; Adherence; Alkalosis; Arrhythmia; Atrial Fibrillation; Bedside Testings; Bicarbonates; Cardioscopes; Cardiovascular Diseases; Cardiovascular system; Caring; Cause of Death; Cessation of life; Clinical Trials; Cross-Over Trials; Data; Dialysis procedure; Dropout; Electrolytes; End stage renal failure; Event; Excision; Expenditure; Failure; Financial compensation; Frequencies; General Population; Goals; Heart Arrest; Hemodialysis; Incidence; Individual; Intervention; Intervention Trial; Life; Link; Liquid substance; Long-Term Effects; Medicare; Monitor; Morbidity - disease rate; Nurses; Patients; Physicians; Pilot Projects; Population; Positioning Attribute; Potassium; Protocols documentation; Randomized; Research Personnel; Risk; Role; Savings; Serum; Stroke; Sudden Death; Technology; Testing; Ultrafiltration; Uremia; base; clinical care; clinical risk; clinically significant; design; experience; feasibility trial; high risk; ineffective therapies; mortality; new technology; novel; novel strategies; patient oriented research; pilot trial; point of care; potassium bicarbonate; prevent; prospective; randomized trial; recruit; retention rate; safety and feasibility; standard of care; trial design

Dialytic removal of fluid, potassium and acid is life-saving in individuals with hemodialysis (HD)-dependent end stage renal disease. However, there is compelling evidence that the dialysis procedure contributes to the risk of serious arrhythmias including sudden cardiac arrest (SCA)—which accounts for roughly 25% of all deaths in HD patients and occurs at a rate 20x that in the general population—and atrial fibrillation (AF)—a highly prevalent condition in HD strongly associated with cardiovascular morbidity, mortality and stroke. Specifically, there are strong and consistent observations linking the dialytic fluid ultrafiltration (UF) rate as well as serum and dialysate potassium and bicarbonate concentrations to fatal and non-fatal arrhythmia. Given the high rates of cardiovascular morbidity and mortality in HD patients and the evidence that standard cardiovascular therapies are ineffective, designing prospective, randomized trials to investigate whether changes to current treatment paradigms regarding modifiable facets of the dialysis prescription will reduce the risk of arrhythmic events represents a novel approach with the strong potential to reduce mortality. Historically, such studies have been unfeasible due to the limits of long-term electrocardiographic monitoring, but new technologies have overcome this challenge: Our unique experience with novel implantable loop recording (ILR) technology in HD patients, and our expertise in HD patient-oriented studies place us in the optimal position to conduct randomized, crossover trials leveraging point of care (POC) electrolyte testing with ILR technology in order to compare the long-term impact of 3 randomized manipulations of the dialysis prescription on arrhythmia: low vs. high serum to dialysate potassium gradient, low vs. high serum-dialysate bicarbonate gradient, and low vs. high ultrafiltration (UF) rates. Our proposed trials will transform understanding of how dialysis prescriptions impact HD-associated arrhythmia and will directly influence clinical care. The current application seeks support under the R34 mechanism to conduct pilot trials designed to: Test the feasibility of POC-guided dialysate potassium and bicarbonate prescriptions as well as the feasibility of limiting UF rate in an HD trial (Aim 1); Analyze recruitment feasibility for trials combining ILR insertion to monitor arrhythmia with POC-guided bicarbonate or potassium prescriptions or UF rate manipulation (Aim 2); and Refine effect estimates for change in arrhythmia frequency with each intervention (Aim 3). These studies will provide unique data on the causal role of dialysis in HD-associated arrhythmia and the information necessary for the design of definitive, large- scale interventional trials with the potential to transform dialysis.

透析清除液体、钾和酸可挽救血液透析（HD）依赖性终末期患者的生命 肾病分期然而，有令人信服的证据表明，透析程序有助于风险 严重的心律失常，包括心脏骤停（SCA）-约占所有死亡的25%， HD患者的发生率是普通人群的20倍，而房颤（AF）是一种高度 HD中的流行疾病与心血管发病率、死亡率和卒中密切相关。具体地说， 存在与透析液超滤（UF）率以及血清相关的强有力且一致的观察结果 以及透析液钾和碳酸氢盐浓度与致命性和非致命性心律失常的关系。鉴于高利率 血液透析患者心血管疾病发病率和死亡率，以及标准心血管疾病 治疗无效，设计前瞻性，随机试验，以调查是否改变目前的治疗方法， 关于透析处方的可修改方面的治疗范例将降低透析的风险。 事件代表了一种新的方法，具有降低死亡率的强大潜力。从历史上看，这些研究 由于长期心电图监测的限制，这些方法是不可行的，但新技术 克服这一挑战：我们在HD中使用新型植入式环路记录（ILR）技术的独特经验 我们在HD患者导向研究方面的专业知识使我们处于开展 利用ILR技术进行床旁（POC）电解质检测的随机交叉试验， 比较透析处方的3种随机操作对心律失常的长期影响：低vs. 高血清-透析液钾梯度、低与高血清-透析液碳酸氢盐梯度以及低与高血清-透析液碳酸氢盐梯度 高超滤（UF）速率。我们提议的试验将改变对透析处方如何 影响HD相关心律失常，并将直接影响临床护理。目前的申请寻求支持 在R34机制下进行试点试验，旨在：测试POC引导透析液的可行性 钾和碳酸氢盐处方以及在HD试验中限制UF率的可行性（目标1）; 分析结合ILR插入监测心律失常与POC引导的试验的招募可行性 碳酸氢盐或钾处方或超滤率操作（目标2）;以及细化变化的效果估计 每次干预的心律失常频率（目标3）。这些研究将提供关于因果关系的独特数据。 透析在HD相关心律失常中的作用以及设计确定性、大型 大规模的干预性试验，有可能改变透析。

项目成果

Point-of-Care Chemistry-Guided Dialysate Adjustment to Reduce Arrhythmias: A Pilot Trial.

护理点化学引导透析液调整以减少心律失常：试点试验。

• DOI: 10.1016/j.ekir.2023.07.039
• 发表时间: 2023-11
• 期刊: KIDNEY INTERNATIONAL REPORTS
• 影响因子: 6
• 作者: Pun, Patrick H.;Santacatterina, Michele;Ways, Javaughn;Redd, Cynthia;Al-Khatib, Sana M.;Smyth-Melsky, Jane;Chinitz, Larry;Charytan, David M.
• 通讯作者: Charytan, David M.