REstrictive versus LIberal rate of Extracorporeal Volume removal Evaluation in Acute Kidney Injury (RELIEVE-AKI)

急性肾损伤（RELIEVE-AKI）体外容量去除评估的限制性与自由性比率

• 批准号: 10364868
• 负责人: Kianoush B Kashani
• 金额: $ 32.88万
• 依托单位: UNIVERSITY OF PITTSBURGH AT PITTSBURGH
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-30 至 2024-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10364868
• 关键词: Acute; Acute Renal Failure with Renal Papillary Necrosis; Antihypertensive Agents; Arrhythmia; Blood flow; Cardiac; Caring; Cessation of life; Clinical Practice Guideline; Clinical Trials; Cluster randomized trial; Critical Care; Critical Illness; Dependence; Diabetes Mellitus; Dialysis procedure; Digestive System Disorders; Evaluation; Excision; Fluid overload; Goals; Health; Hemodialysis; Hospital Mortality; Hospitals; Hour; Hypotension; Injury; Injury to Kidney; Institutes; Intensive Care Units; Kidney Diseases; Kidney Failure; Knowledge; Length of Stay; Liquid substance; Measures; Mechanical ventilation; Mission; Morbidity - disease rate; Multi-Institutional Clinical Trial; Myocardial Ischemia; Observational Study; Organ; Outcome; Outpatients; Patient Recruitments; Patient-Focused Outcomes; Patients; Phase; Physicians; Population; Positioning Attribute; Pragmatic clinical trial; Protocols documentation; Randomized; Randomized Clinical Trials; Renal Replacement Therapy; Renal function; Residual state; Risk; System; Time; Ultrafiltration; Unit of Measure; Work; adherence rate; clinical center; clinical practice; comparative effectiveness; design; effective therapy; evidence base; experience; improved; improved outcome; mortality; mortality risk; patient oriented; pragmatic trial; randomized trial; recruit; response; safety outcomes; secondary analysis; secondary outcome; therapy design; treatment arm; treatment group

Abstract Two-thirds of critically ill patients with acute kidney injury have a fluid overload at the time of initiation of kidney replacement therapy in the intensive care unit. Although “net ultrafiltration (UFNET),” also known as net fluid removal during kidney replacement therapy, has been used in the treatment of fluid overload for more than seven decades, the optimal rate of UFNET remains uncertain, complications such as hypotension and cardiac arrhythmias occur frequently, and more than 40% of critically ill patients die. Emerging evidence from observational studies suggests a “J” shaped association between UFNET rate and mortality in critically ill patients with acute kidney injury and treated with kidney replacement therapy. Higher UFNET rates are associated with an increased risk of death compared with moderate and lower UFNET rates. Understanding the causal effects of UFNET rate on outcomes is critical to design interventions to reduce mortality, develop evidence-based clinical practice guidelines, and implement quality measures for UFNET. In the absence of such knowledge, optimizing UFNET to improve outcomes will remain problematic. Thus, we will conduct a pilot clinical trial entitled REstrictive versus LIberal rate of Extracorporeal Volume removal Evaluation in Acute Kidney Injury (RELIEVE-AKI) to examine the feasibility of restrictive compared with a liberal UFNET rate strategy. The study is a stepped-wedge cluster-randomized trial involving 144 critically ill patients with acute kidney injury and treated with continuous kidney replacement therapy in six intensive care units across two hospital systems. The intensive care units will be randomized 1:1 in which patients will receive either a restrictive or a liberal UFNET rate strategy. Both strategies are standards of care and are commonly used in current clinical practice. In the restrictive group, the UFNET rate will be titrated and maintained between 0.5-1.5 mL/kg/h. In the liberal group, the UFNET rate will be titrated and maintained between of 2.0-5.0 mL/kg/h. The primary feasibility outcomes are between-group differences in patient mean delivered UFNET rates, protocol adherence, and rate of patient recruitment (Aim 1). We will also explore the effects of alternative UFNET rate strategies on secondary outcomes including hypotensive episodes, and cardiac arrhythmias; emergent use of rescue UFNET rates higher than the assigned treatment arm for fluid overload; duration of kidney replacement therapy and mechanical ventilation; intensive care unit and hospital length of stay, and independence from kidney replacement therapy and hospital mortality (Aim 2). This pragmatic clinical trial will be used to support the rationale, assess feasibility, and design a phase III multicenter randomized trial to examine the effects of alternative UFNET rate strategies on patient-centered clinical outcomes. Our study will have a direct impact on the care of critically ill patients with acute kidney injury and thus will influence clinical practice, physicians, and policymakers.

抽象的 三分之二的急性肾脏损伤患者在肾脏开始时患有液体超负荷 重症监护病房的替代疗法。虽然“净超滤（UFNET）”，但也称为净流体 在肾脏替代疗法期间清除，已用于治疗液体超负荷的治疗 七十年来，UFNET的最佳速率仍然不确定，并发症，例如低血压和心脏 心律不齐经常发生，超过40％的重症患者死亡。来自新兴的证据 观察性研究表明，在危重患病中，UFNET率与死亡率之间存在“ J”形的关联 急性肾脏损伤的患者并接受肾脏替代疗法治疗。较高的UFNET率为 与中等和较低的UFNET率相比，与死亡风险增加有关。了解 UFNET率对结果的因果影响对于设计干预措施以降低死亡率，发展至关重要 基于证据的临床实践指南，并实施UFNET的质量措施。在没有这样的情况下 知识，优化UFNET改善结果将保持问题。那，我们将进行飞行员临床 急性肾脏损伤中的限制性限制与自由度的限制性与自由率 （缓解Aki）与自由ufnet率策略相比，检查限制性的可行性。这项研究是 一项阶梯式悬挂群集随机试验，涉及144例急性肾脏损伤患者并接受治疗 在两个医院系统的六个重症监护病房中连续肾脏替代疗法。这 重症监护病房将被随机分配1：1，患者将获得限制性或自由主义的UFNET 费率策略。两种策略都是护理标准，通常用于当前临床实践。在 限制性组，UFNET速率将滴定并保持在0.5-1.5 ml/kg/h之间。在自由团体中， UFNET速率将滴定和维持在2.0-5.0 mL/kg/h之间。主要的可行性结果是 患者平均分配的UFNET率，协议依从性和患者速率的组间差异 招聘（目标1）。我们还将探讨替代UFNET速率策略对次要的影响 包括降压发作和心律不齐的结果；紧急使用救援UFNET费率 高于分配的用于流体超负荷的治疗臂；肾脏替代疗法的持续时间和 机械通气；重症监护室和住院时间长度，以及肾脏独立 替代疗法和医院死亡率（AIM 2）。这项务实的临床试验将用于支持 基本原理，评估可行性和设计III期多中心随机试验，以检查 以患者为中心的临床结果的替代UFNET费率策略。我们的研究将直接影响 急性肾脏损伤的重症患者的护理，因此会影响临床实践，医生和 决策者。