Kidney Support in Pediatric Patients Using an Ultrafiltration Device

使用超滤装置为儿科患者提供肾脏支持

• 批准号: 10407077
• 负责人: Robert J Knuesel
• 金额: $ 76.31万
• 依托单位: KORONIS BIOMEDICAL TECHNOLOGIES CORPORAT
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-05-18 至 2024-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10407077
• 关键词: Acidosis; Acute; Acute Renal Failure with Renal Papillary Necrosis; Adult; Alabama; Biomedical Technology; Blood; Blood Platelets; Blood Vessels; Blood Volume; Blood donor; Blood flow; Caring; Catheters; Child; Childhood; Clinical; Clinical Research; Clinical Trials; Coagulation Process; Collaborations; Computer software; Consult; Convection; Critical Illness; Critically ill children; Development; Devices; Doctor of Philosophy; Engineering; Ensure; Evaluation; Evaluation Studies; Fluid Balance; Fluid overload; Hemofiltration; Hospitals; Human; Hypocalcemia; Hypotension; Incidence; Infant; Infusion Pumps; Internal jugular vein structure; Kidney; Kidney Failure; Lead; Liquid substance; Literature; Medical center; Membrane; Metabolic Clearance Rate; Methods; Morbidity - disease rate; Multi-Institutional Clinical Trial; Nephrology; Outcome; Patients; Pediatric Hospitals; Performance; Phase; Plasma; Population; Premature Infant; Principal Investigator; Pump; Renal Replacement Therapy; Research; Research Personnel; Resources; Retrospective Studies; Risk; Safety; Saline; Scientist; Small Business Innovation Research Grant; Software Design; System; Systems Development; Technology; Ultrafiltration; Universities; Venovenous Hemofiltrations; Washington; Waste Products; base; clinical center; design; experience; hemodynamics; high risk; hyperkalemia; mortality; neonate; operation; pediatric patients; pressure; professor; safety study; usability; verification and validation

Abstract Koronis Biomedical Technologies (KBT) proposes to develop and fully evaluate a renal replacement therapy (RRT) machine specifically targeted for critically-ill small children and neonates with acute kidney injury (AKI), fluid overload, and kidney failure. In recent years, continuous renal replacement therapy (CRRT) has emerged as the preferred method for providing kidney support to these patients, especially those who are hemodynamically unstable. Continuous veno-venous hemofiltration (CVVH) is a form of CRRT built on hemofiltration: waste products and fluid in plasma are removed from the blood by a pressure gradient over a filter, while a replacement fluid is infused to maintain fluid balance. Unfortunately, neonates infrequently receive renal replacement therapy due to the technical challenges of traditional CRRT machines that make therapy initiation very difficult, even at experienced tertiary children’s hospitals. Machines designed for adult- sized patients, but commonly used in pediatric care, require large catheters, tubing, and filters. This results in a high extracorporeal volume (ECV, the total volume of blood in the external circuit—the tubing and hemofilter) relative to a small patient’s size, as well as higher blood flows, higher clearance rates, and higher risks. Numerous medical centers do not even offer CRRT to infants, let alone for critically-ill neonates or premature infants, due to the inherent risks. At therapy initiation, a volume of fluid roughly equivalent to the ECV must be injected into the blood circuit to “prime” the pump. For CRRT in larger children and adults, the priming fluid is simply saline. If, however, the amount of fluid required to prime the circuit is greater than 10% of the patient’s total blood volume, the saline fluid could significantly dilute the patient’s blood, leading to hemodynamic instability. To avoid this outcome, a donor “blood prime” is used, though it is not without risks, such as hypocalcemia, acidosis, hyperkalemia, and a loss of platelets and coagulation functions. KBT’s Phase II SBIR project proposes to bring a new CRRT device with a lower ECV to market that is specifically targeted for small children and neonates, eliminating the need for blood primes. The performance and safety of the proposed highly integrated CRRT system will be evaluated in a clinical trial.

抽象的 Koronis Biomedical Technologies (KBT) 提议开发并全面评估肾脏替代疗法 (RRT) 机器专门针对患有急性肾损伤 (AKI) 的危重幼儿和新生儿， 液体超负荷和肾衰竭。近年来出现了连续性肾脏替代治疗（CRRT） 作为为这些患者（尤其是那些患有以下疾病的患者）提供肾脏支持的首选方法 血流动力学不稳定。连续静脉-静脉血液滤过 (CVVH) 是 CRRT 的一种形式 血液过滤：血浆中的废物和液体通过压力梯度从血液中去除 过滤器，同时注入替换液以维持液体平衡。不幸的是，新生儿很少 由于传统 CRRT 机器的技术挑战，接受肾脏替代治疗 即使在经验丰富的三级儿童医院，开始治疗也非常困难。专为成人设计的机器- 体型较大的患者（但常用于儿科护理）需要大型导管、管道和过滤器。这导致 高体外容量（ECV，外部回路（管道和滤血器）中的血液总量） 相对于小患者的体型，以及更高的血流量、更高的清除率和更高的风险。 许多医疗中心甚至不为婴儿提供 CRRT，更不用说危重新生儿或早产儿了 婴儿，由于固有的风险。治疗开始时，必须注入大致相当于 ECV 的液体量 注入血液回路以“启动”泵。对于较大儿童和成人的 CRRT，预充液是 只是生理盐水。然而，如果灌注回路所需的液体量大于患者体内液体量的 10% 总血容量，盐水可以显着稀释患者的血液，导致血流动力学改变 不稳定。为了避免这种结果，使用了捐赠者“血液初等”，尽管它并非没有风险，例如 低钙血症、酸中毒、高钾血症以及血小板和凝血功能丧失。 KBT 第二阶段 SBIR 该项目提议将一种具有较低 ECV 的新型 CRRT 设备推向市场，专门针对小型设备 儿童和新生儿，无需进行血液预充。拟议的性能和安全性 高度集成的 CRRT 系统将在临床试验中进行评估。