Zonnebeld Niek, Huberts Wouter, van Loon Magda M, Delhaas Tammo, Tordoir Jan H M
Department of Biomedical Engineering, Cardiovascular Research Institute Maastricht (CARIM), Faculty of Health, Medicine and Life Sciences, Maastricht University, Maastricht - The Netherlands.
Department of Vascular Surgery, Maastricht University Medical Center+, Maastricht - The Netherlands.
J Vasc Access. 2017 Mar 6;18(Suppl. 1):118-124. doi: 10.5301/jva.5000661. Epub 2017 Mar 5.
The arteriovenous fistula (AVF) is the preferred vascular access for hemodialysis patients. Unfortunately, 20-40% of all constructed AVFs fail to mature (FTM), and are therefore not usable for hemodialysis. AVF maturation importantly depends on postoperative blood volume flow. Predicting patient-specific immediate postoperative flow could therefore support surgical planning. A computational model predicting blood volume flow is available, but the effect of blood flow predictions on the clinical endpoint of maturation (at least 500 mL/min blood volume flow, diameter of the venous cannulation segment ≥4 mm) remains undetermined.
A multicenter randomized clinical trial will be conducted in which 372 patients will be randomized (1:1 allocation ratio) between conventional healthcare and computational model-aided decision making. All patients are extensively examined using duplex ultrasonography (DUS) during preoperative assessment (12 venous and 11 arterial diameter measurements; 3 arterial volume flow measurements). The computational model will predict patient-specific immediate postoperative blood volume flows based on this DUS examination. Using these predictions, the preferred AVF configuration is recommended for the individual patient (radiocephalic, brachiocephalic, or brachiobasilic). The primary endpoint is FTM rate at six weeks in both groups, secondary endpoints include AVF functionality and patency rates at 6 and 12 months postoperatively.
ClinicalTrials.gov (NCT02453412), and ToetsingOnline.nl (NL51610.068.14).
动静脉内瘘（AVF）是血液透析患者首选的血管通路。不幸的是，所有构建的AVF中有20%-40%未能成熟（FTM），因此无法用于血液透析。AVF的成熟主要取决于术后血容量流量。因此，预测患者特异性的术后即刻流量可为手术规划提供支持。已有一个预测血容量流量的计算模型，但血流预测对成熟这一临床终点（至少500毫升/分钟的血容量流量，静脉插管段直径≥4毫米）的影响仍未确定。
将进行一项多中心随机临床试验，372名患者将在传统医疗护理和计算模型辅助决策之间进行随机分组（分配比例为1:1）。在术前评估期间，所有患者均使用双功超声检查（DUS）进行全面检查（测量12处静脉和11处动脉直径；测量3次动脉血容量流量）。计算模型将基于此DUS检查预测患者特异性的术后即刻血容量流量。利用这些预测结果，为个体患者推荐首选的AVF配置（桡动脉-头静脉、肱动脉-头静脉或肱动脉-尺静脉）。主要终点是两组六周时的FTM率，次要终点包括术后6个月和12个月时的AVF功能和通畅率。
ClinicalTrials.gov（NCT02453412）和ToetsingOnline.nl（NL51610.068.14）。
