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.

摘要 Koronis Biomedical Technologies（KBT）建议开发并全面评估肾脏替代疗法 (RRT)专门针对患有急性肾损伤（阿基）的危重幼儿和新生儿的机器， 体液过多和肾衰竭近年来，连续性肾脏替代治疗（CRRT）应运而生 作为向这些患者提供肾脏支持的优选方法，特别是那些 血流动力学不稳定连续性静脉-静脉血液滤过（CVVH）是一种CRRT， 血液滤过：血浆中的废物和液体通过在一定压力下的压力梯度从血液中除去。 过滤器，同时输注置换液以保持液体平衡。不幸的是，新生儿很少 由于传统CRRT机的技术挑战， 治疗启动非常困难，即使在有经验的三级儿童医院。为成人设计的机器- 大的患者，但通常用于儿科护理，需要大的导管、管道和过滤器。这导致 高体外容量（ECV，外部回路-管路和血液滤过器中的血液总量） 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。在治疗开始时，必须注入大致相当于ECV的液体体积。 注射到血液回路中以“灌注”泵。对于较大儿童和成人的CRRT，预充液为 只是盐水。但是，如果预充回路所需的液体量大于患者的10%， 总血容量，生理盐水可显著稀释患者的血液，导致血流动力学 不稳定为了避免这种结果，使用供体“血液预充”，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的第二阶段SBIR 该项目建议将一种ECV较低的新型CRRT器械推向市场，专门针对小型 儿童和新生儿，消除了对血液预充的需要。性能和安全性的建议 将在临床试验中评价高度集成的CRRT系统。