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.

血液透析（HD）依赖性端的个体中的透明度去除液，钾和酸是挽救生命的 阶段肾脏疾病。但是，有令人信服的证据表明透析程序有助于风险 严重心律不齐包括猝死（SCA），大约占所有死亡人数的25％ 高清患者，以20倍的速度发生，在普通人群中（和心房纤颤（AF）） HD的流行状况与心血管发病率，死亡率和中风密切相关。具体来说， 有很强且一致的观察结果，将透明体流体超滤（UF）速率以及串行 以及致命性和非致命性心律不齐的透析液和碳酸氢盐浓度。考虑到高率 HD患者的心血管发病率和死亡率以及标准心血管的证据 疗法无效，设计了前瞻性，随机试验，以调查当前的变化 有关透析处方的可修改方面的治疗范例将降低心律不齐的风险 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，这样的研究 由于长期心电图监测的限制，这是不可行的，但是新技术具有 克服这一挑战：我们在HD中使用新颖的可植入循环记录（ILR）技术的独特经验 患者以及我们在高清患者面向患者的研究方面的专业知识使我们处于最佳位置 使用ILR技术的随机，跨界试验利用护理点（POC）电解质测试 比较透析处方对心律不齐的3个随机操作的长期影响：低与低。 高血清至透析液钾的梯度，低血清和高血清溶剂液碳酸氢盐梯度和低VS。 高超滤（UF）率。我们提出的试验将改变人们对透析处方的理解 影响与HD相关的心律不齐，并将直接影响临床护理。当前申请寻求支持 在R34的机制下进行试点试验，旨在：测试POC引导的透析液的可行性 钾和碳酸氢盐处方以及在高清试验中限制UF率的可行性（AIM 1）； 分析招募可行性，用于结合ILR插入以监测心律失常与POC引导的试验可行性 碳酸氢盐或钾的处方或UF费率操纵（AIM 2）；和更改的完善效应估计 每次干预措施中的心律不齐频率（AIM 3）。这些研究将提供有关因果的独特数据 透析在与HD相关的心律不齐中的作用以及设计确定性，大型设计所必需的信息 规模介入试验可能会改变透析。

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.

In-Hospital Cardiopulmonary Resuscitation in Patients Receiving Maintenance Dialysis: Glass Half Full or Half Empty?

• DOI: 10.1016/j.xkme.2021.10.012
• 发表时间: 2022-01
• 期刊: Kidney medicine
• 影响因子: 3.9
• 作者: Pun PH