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生物医学技术（KBT）提案，以开发和充分评估肾脏替代疗法 （RRT）专门针对急性肾脏损伤（AKI）的批判性小孩和新生儿的机器， 液体超负荷和肾衰竭。近年来，连续肾脏替代疗法（CRRT）出现了 作为向这些患者提供肾脏支持的首选方法，尤其是那些 血液动力学不稳定。连续静脉血液滤过（CVVH）是建立在 血液滤过：废物产物和血浆中的液体通过压力梯度从血液中去除 过滤，而替换流体被注入以保持流体平衡。不幸的是，新生儿很少经常 由于传统CRRT机器的技术挑战，接受肾脏替代疗法 即使在经验丰富的三级儿童医院，治疗倡议也非常困难。为成人设计的机器 大小的患者，但通常用于小儿护理，需要大型导管，管道和过滤器。这导致 体外体积高（ECV，外回路中的血液总量 - 管道和血液滤池） 相对于小患者的大小以及更高的血液流动，更高的清除率和更高的风险。 许多医疗中心甚至没有为婴儿提供CRRT，更不用说批判性的新生儿或早产 婴儿，由于继承风险。在治疗计划中，大约等同于ECV的流体必须为 注射到血回路中以“启动”泵。对于较大儿童和成人的CRRT，启动液为 只是盐水。但是，如果电路需要的流体量大于患者的10％ 总血量，盐水液可以显着稀释患者的血液，导致血液动力学 不稳定。为了避免这种结果，使用捐赠者“血统”，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结功能的丧失。 KBT的II期SBIR 项目提案将带有ECV较低的新的CRRT设备带入市场，该设备专门针对小型 儿童和新生儿，消除了对血液素的需求。提议的性能和安全性 高度集成的CRRT系统将在临床试验中进行评估。