Recommended Clinical Trial End Points for Dialysis Catheters
Recommended Clinical Trial End Points for Dialysis Catheters
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透析导管推荐的临床试验终点
DOI：
10.2215/cjn.12011116
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发表时间：
2018-03-07
影响因子：
9.8
通讯作者：
Wasse, Haimanot
中科院分区：
文献类型：
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作者：
Allon, Michael;Brouwer-Maier, Deborah J.;Wasse, Haimanot
血液透析患者经常使用中心静脉导管作为永久血管通路的桥梁。它们容易出现频繁的并发症，包括导管相关的血流感染、导管功能障碍和中心静脉阻塞。迫切需要开发新的药物或装置来预防中心静脉导管并发症。我们召集了一个多学科专家小组，提出了导管终点的标准化定义，以指导未来寻求美国食品和药物管理局批准的临床试验的设计。我们的工作组建议对临床怀疑感染（发烧、寒战、精神状态改变或不明原因低血压）的依赖导管的血液透析患者诊断导管相关血流感染，从导管毂和外周静脉（或透析血统）进行血培养培养出相同的微生物，并且缺乏其他感染源的证据。导管功能障碍被定义为中心静脉导管无法 (1) 完成单次透析而不触发重复的压力警报，或 (2) 在连续两次透析过程中可重复地提供 > 300 ml/min 的平均透析血流量（动脉和静脉压力在血液透析装置参数范围内），或在 4 小时或更短的时间内提供 Kt/V >= 1.2。仅当导管功能障碍持续存在时才定义为导管功能障碍，尽管尝试重新定位患者、颠倒动脉和静脉线路或用力冲洗导管。通过对比静脉造影或等效检查发现中央静脉狭窄 > 70%、同侧上肢水肿、以及现有或既往有中心静脉导管史的患者应怀疑中央静脉阻塞。这些诊断的具体标准存在一些不确定性，工作组还提出了未来的高度优先研究来解决这些问题。
Central venous catheters are used frequently in patients on hemodialysis as a bridge to a permanent vascular access. They are prone to frequent complications, including catheter-related bloodstream infection, catheter dysfunction, and central vein obstruction. There is a compelling need to develop new drugs or devices to prevent central venous catheter complications. We convened a multidisciplinary panel of experts to propose standardized definitions of catheter end points to guide the design of future clinical trials seeking approval from the Food and Drug Administration. Our workgroup suggests diagnosing catheter-related bloodstream infection in catheter-dependent patients on hemodialysis with a clinical suspicion of infection (fever, rigors, altered mental status, or unexplained hypotension), blood cultures growing the same organism from the catheter hub and a peripheral vein (or the dialysis bloodline), and absence of evidence for an alternative source of infection. Catheter dysfunction is defined as the inability of a central venous catheter to (1) complete a single dialysis session without triggering recurrent pressure alarms or (2) reproducibly deliver a mean dialysis blood flow of > 300 ml/min (with arterial and venous pressures being within the hemodialysis unit parameters) on two consecutive dialysis sessions or provide a Kt/V >= 1.2 in 4hours or less. Catheter dysfunctionis defined only if it persists, despite attempts to reposition the patient, reverse the arterial and venous lines, or forcefully flush the catheter. Central vein obstruction is suspected in patients with > 70% stenosis of a central vein by contrast venography or the equivalent, ipsilateral upper extremity edema, and an existing or prior history of a central venous catheter. There is some uncertainty about the specific criteria for these diagnoses, and the workgroup has also proposed future high-priority studies to resolve these questions.