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

基本信息

批准号：
10620178
负责人：
Robert J Knuesel
金额：
$ 37.83万
依托单位：
KORONIS BIOMEDICAL TECHNOLOGIES CORPORAT
依托单位国家：
美国
项目类别：
财政年份：
2021
资助国家：
美国
起止时间：
2021-05-18 至 2025-04-30
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10620178
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 Convection Critical Illness Critically ill children Development Devices Doctor of Philosophy Engineering Ensure Evaluation Evaluation Studies Femur Fluid Balance Fluid overload Hemofiltration Hospitals Human Hypocalcemia Hypotension Incidence Infant Infusion Pumps Internal jugular vein structure Kidney Kidney Failure Liquid substance Literature Marketing 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 Qualifying Renal Replacement Therapy Research Research Personnel Resources Retrospective Studies Risk Safety Saline Scientist Small Business Innovation Research Grant Software Design Specific qualifier value System Systems Development Technology Tube Ultrafiltration Universities Venovenous Hemofiltrations Washington Waste Products base design design verification experience hemodynamics high risk hyperkalemia mortality neonate operation pediatric patients pressure professor safety study usability

项目摘要

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，近年来出现了连续性肾脏替代疗法（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) 是建立在 CRRT 基础上的一种形式。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不幸的是，新生儿很少使用过滤器，同时注入替代液以维持液体平衡。由于传统 CRRT 机器的技术挑战，肾脏接受替代治疗即使在经验丰富的三级儿童医院，治疗开始也非常困难。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。高体外容量（ECV，外部回路（管道和滤血器）中的血液总量）相对于较小的患者体型，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对于婴儿，由于固有的风险，在治疗开始时，液体量必须大致等于 ECV。注入血液回路以“灌注”泵对于较大儿童和成人的 CRRT，灌注液是。然而，如果灌注回路所需的液体量大于患者液体量的 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为了避免这种不稳定的结果，使用了捐赠者“血液素”，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。项目提案将一种具有较低 ECV 的新型 CRRT 设备推向市场，该设备专门针对小型设备儿童和新生儿，消除了血液素的需要建议的性能和安全性。高度集成的 CRRT 系统将在临床试验中进行评估。