MethLock vs. heparin as dialysis catheter lock

MethLock 与肝素作为透析导管锁

• 批准号: 7264869
• 负责人: STEPHEN R ASH
• 金额: $ 176.21万
• 依托单位: ASH ACCESS TECHNOLOGY, INC.
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-09-01 至 2008-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7264869
• 关键词: Adverse event; Anti-Bacterial Agents; Anticoagulants; Bacteremia; Bacteria; Blood; Blood specimen; Caring; Case Report Form; Catheter-related bloodstream infection; Catheters; Clinical; Clinical Treatment; Clinical Trials; Clinical trial protocol document; Culture Media; Data; Dialysis procedure; Drug Evaluation; Effectiveness; End Point; End stage renal failure; Enrollment; Excision; Failure; Grant; Guidelines; Hemodialysis; Heparin; In Vitro; Incidence; Infection; Intervention; Measurable; Medical Staff; Methylene blue; Modification; Multicenter Studies; Multicenter Trials; Numbers; Patients; Peripheral; Phase; Physical Dialysis; Pilot Projects; Property; Protocols documentation; Pseudomonas; Publishing; Randomized Controlled Clinical Trials; Rate; Research; Research Ethics Committees; Risk; Safety; Sepsis; Site; Solutions; Speed; Standards of Weights and Measures; Testing; Time; United States Food and Drug Administration; Venous; bactericide; follow-up; peripheral blood; pilot trial; size; sodium citrate; staff intervention

Currently about 25% of patients on hemodialysis therapy for End Stage Renal Disease (ESRD) receive dialysis through tunneled central venous catheters for dialysis (CVCD). The standard anticoagulant lock for these catheters is heparin, which has no antibacterial properties. The greatest risk for ESRD patients using CVCDs access is catheter related bloodstream infection ; (CRBSI), with frequent progression to sepsis. MethLock ¿ is a catheter lock comprised of methylene blue (an antibacterial substance) and sodium citrate (7%, an anticoagulant). In vitro ; studies of MethLock have shown that it is bactericidal for all bacteria, even in the presence of diluted blood or culture medium. This Phase I and Phase II grant will support a multicenter randomized trial of the safety and effectiveness of MethLock versus heparin as a catheter lock in tunneled CVCD. The protocol has been approved by the FDA and an IDE granted for MethLock for the trial. The primary endpoints are CRBSI (concordant bacterial culture drawn from peripheral blood and the catheter lumen) and removal of the catheter for patency failure (after demonstration of at least 25% decrease in flow rate during dialysis versus a baseline treatment). Each patient will be followed for up to 6 months, and the size of the study (400 patients) will provide enough data to demonstrate whether MethLock decreases the incidence CRBSI versus heparin while maintaining patency of catheters equal to heparin. The endpoints of the study are objective and easily definable but have not been validated in a full-scale clinical trial of CVCD or catheter lock. In Phase Iwe will implement the protocol at one dialysis center (a "pilot" center) to determine the practicality of the trial, analyzing: the ease of patient enrollment, speed of identification of adverse events, and the general correlation between our defined endpoints and clinical interventions by staff on theCVCDs. After Phase I we will determine whether the protocol needs to be modified and if so will request protocol modifications from the FDA. In Phase II we will implement the protocol in a number of dialysis centers and complete the study as originally proposed or as modified after Phase I.

目前约有25％的血液透析治疗患者治疗终末期肾脏疾病（ESRD） 通过隧道的中央静脉导管接受透析（CVCD）。标准 这些导管的抗凝锁是肝素，没有抗菌特性。 使用CVCD的ESRD患者最大的风险是导管相关的血液感染； （CRBSI），频繁发展为败血症。 Methlock„是一个已完成的导管锁 亚甲基蓝（一种抗菌物质）和柠檬酸钠（7％，抗凝剂）。体外; 对甲锁的研究表明，即使在存在的情况下 稀释的血液或培养基。 I阶段和第二阶段赠款将支持多中心 将甲锁与肝素作为导管锁的安全性和有效性的随机试验 隧道CVCD。该协议已由FDA批准，并授予Methlock的IDE 试验。主要终点是CRBSI（从周围绘制的一致细菌培养 血液和导管腔）和去除导管以进行通畅失败（演示后 与基线治疗相比，透析期间的流量至少降低了25％）。每个患者都会 遵循最多6个月，研究的规模（400名患者）将提供足够的数据 证明Methlock在维持的同时是否拒绝了CRBSI与肝素的事件 导管的通畅与肝素相等。研究的终点是客观的，很容易定义 但是在CVCD或导管锁的全尺度临床试验中尚未得到证实。在IWE阶段将 在一个透析中心（一个“飞行员”中心）中实施协议，以确定 试验，分析：患者入学率的便利性，不良事件的识别速度以及 我们确定的终点与工作人员在theCVCD上进行的临床干预之间的一般相关性。 第一阶段之后，我们将确定是否需要修改协议，是否需要请求 FDA的协议修改。在第二阶段，我们将在许多人中实施该协议 透析中心并完成该研究。