Renal, Electrolyte and Hypertension Division, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA.
Department of Quantitative Health Sciences, Cleveland Clinic, Cleveland, OH.
Am J Kidney Dis. 2014 Jan;63(1):104-12. doi: 10.1053/j.ajkd.2013.06.024. Epub 2013 Aug 28.
A large proportion of newly created arteriovenous fistulas cannot be used for dialysis because they fail to mature adequately to support the hemodialysis blood circuit. The Hemodialysis Fistula Maturation (HFM) Study was designed to elucidate clinical and biological factors associated with fistula maturation outcomes.
Multicenter prospective cohort study.
SETTING & PARTICIPANTS: Approximately 600 patients undergoing creation of a new hemodialysis fistula will be enrolled at 7 centers in the United States and followed up for as long as 4 years.
Clinical, anatomical, biological, and process-of-care attributes identified pre-, intra-, or postoperatively.
The primary outcome is unassisted clinical maturation, defined as successful use of the fistula for dialysis for 4 weeks without maturation-enhancing procedures. Secondary outcomes include assisted clinical maturation, ultrasound-based anatomical maturation, fistula procedures, fistula abandonment, and central venous catheter use.
Preoperative ultrasound arterial and venous mapping, flow-mediated and nitroglycerin-mediated brachial artery dilation, arterial pulse wave velocity, and venous distensibility; intraoperative vein tissue collection for histopathologic and molecular analyses; postoperative ultrasounds at 1 day, 2 weeks, 6 weeks, and prior to fistula intervention and initial cannulation.
Assuming complete data, no covariate adjustment, and unassisted clinical maturation of 50%, there will be 80% power to detect ORs of 1.83 and 1.61 for dichotomous predictor variables with exposure prevalences of 20% and 50%, respectively.
Exclusion of 2-stage transposition fistulas limits generalizability. The requirement for study visits may result in a cohort that is healthier than the overall population of patients undergoing fistula creation.
The HFM Study will be of sufficient size and scope to: (1) evaluate a broad range of mechanistic hypotheses, (2) identify clinical practices associated with maturation outcomes, (3) assess the predictive utility of early indicators of fistula outcome, and (4) establish targets for novel therapeutic interventions to improve fistula maturation.
大量新创建的动静脉瘘不能用于透析，因为它们不能充分成熟以支持血液透析回路。动静脉瘘成熟（HFM）研究旨在阐明与瘘成熟结果相关的临床和生物学因素。
多中心前瞻性队列研究。
在美国的 7 个中心，大约 600 名接受新血液透析瘘创建的患者将被纳入研究，并随访长达 4 年。
术前、术中和术后确定的临床、解剖学、生物学和护理过程属性。
主要结局是未经辅助的临床成熟，定义为瘘管在未经成熟增强治疗的情况下成功用于透析 4 周。次要结局包括辅助临床成熟、超声解剖学成熟、瘘管手术、瘘管废弃和中央静脉导管使用。
术前超声动脉和静脉映射、血流介导和硝酸甘油介导的肱动脉扩张、动脉脉搏波速度和静脉顺应性；术中静脉组织采集用于组织病理学和分子分析；术后 1 天、2 周、6 周和瘘管干预及初次插管前进行超声检查。
假设完全数据、无协变量调整和未经辅助的临床成熟率为 50%，则对于暴露率分别为 20%和 50%的二分类预测变量，检测比值比（OR）为 1.83 和 1.61 的效力为 80%。
排除 2 期转位瘘限制了其普遍性。研究访视的要求可能会导致研究队列比接受瘘管创建的患者总体人群更健康。
HFM 研究的规模和范围足以：（1）评估广泛的机制假设；（2）确定与成熟结果相关的临床实践；（3）评估瘘管结果早期指标的预测效用；（4）为改善瘘管成熟的新治疗干预措施建立目标。
