MethLock vs. heparin as dialysis catheter lock

MethLock 与肝素作为透析导管锁

基本信息

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
项目类别：
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

项目摘要

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% 的患者因终末期肾病 (ESRD) 接受血液透析治疗通过隧道式中心静脉导管进行透析（CVCD）的标准。这些导管的抗凝剂是肝素，它没有抗菌特性。使用 CVCD 接入的 ESRD 患者的最大风险是导管相关的血流感染； (CRBSI)，经常进展为败血症 ¿是一个导管锁，包括亚甲蓝（一种抗菌物质）和柠檬酸钠（7%，一种体外抗凝剂）。 MethLock 的研究表明，即使存在细菌，它也能杀菌稀释的血液或培养基这一第一阶段和第二阶段拨款将支持多中心。 MethLock 与肝素作为导管锁定剂的安全性和有效性的随机试验该协议已获得 FDA 批准，并为 MethLock 授予了 IDE。试验的主要终点是 CRBSI（从外周血中提取的一致细菌培养物）。血液和导管内腔），并因通畅失败而拔除导管（经过论证后）与基线治疗相比，透析期间流速至少降低 25%）。随访长达 6 个月，研究规模（400 名患者）将提供足够的数据证明与肝素相比，MethLock 是否可以降低 CRBSI 的发生率，同时维持导管的通畅性与肝素相同该研究的终点是客观且易于定义的。但尚未在 CVCD 或导管锁的全面临床试验中得到验证。在一个透析中心（“试点”中心）实施该方案以确定该方案的实用性试验，分析：患者入组的难易程度、不良事件的识别速度以及我们定义的终点与 CVCD 工作人员的临床干预之间的一般相关性。在第一阶段之后，我们将确定协议是否需要修改，如果需要修改，我们将请求 FDA 对协议进行了修改。在第二阶段，我们将在多个国家实施该协议。透析中心并按照最初提议或第一阶段后修改的方式完成研究。