Gonzalo Begoña, Videla Sebastian, Espinar Emma, Palacios Siloé, Herranz Carolina, Iborra Ortega Elena
Angiology, Vascular and Endovascular Surgery Department, Bellvitge University Hospital, Carrer de la Feixa Llarga, s/n, 08907 - L'Hospitalet de Llobregat, Barcelona, Spain
Bio Heart Cardiovascular Diseases Research Group, Bellvitge Institute for Biomedical Research, L'Hospitalet de Llobregat, Barcelona, Spain.
BMJ Open. 2025 Jan 2;15(1):e093911. doi: 10.1136/bmjopen-2024-093911.
Chronic hand ischaemia may affect some haemodialysis patients with an arteriovenous fistula (AVF) or graft (AVG), a condition known as haemodialysis access-induced distal ischaemia (HAIDI). Duplex ultrasonography (DUS) can provide comprehensive insights into anatomical and perfusion properties, and measuring the hand acceleration time (HAT) has been demonstrated to be sensitive within the framework of chronic upper limb ischaemia.
This single-centre, prospective cohort study will involve adult end-stage renal disease (ESRD) patients requiring either AVF or AVG for haemodialysis. The primary outcome will be HAT values (measured at the radial, ulnar and four hand arteries) before and after surgery. Secondary outcomes will include the incidence of HAIDI, vascular access patency, and the incidence of complications. A sample size of 126 subjects will be required to estimate HAIDI incidence with a 95% CI and ±5% precision. Statistical analyses will involve paired t-tests to compare preoperative and postoperative HAT values and determine optimal HAT cut-off values for diagnosing HAIDI.
This study was approved by the Bellvitge University Hospital Institutional Review Board (PR 201/23). Written informed consent will be obtained from all study participants before any study-related procedure is performed. Results will be published in peer-reviewed journals.
ClinicalTrial.gov: NCT06187207. Pre Results.
慢性手部缺血可能影响一些患有动静脉内瘘（AVF）或移植物（AVG）的血液透析患者，这种情况被称为血液透析通路诱导的远端缺血（HAIDI）。双功超声检查（DUS）可以提供有关解剖和灌注特性的全面见解，并且在慢性上肢缺血的背景下，测量手部加速时间（HAT）已被证明是敏感的。
这项单中心前瞻性队列研究将纳入需要AVF或AVG进行血液透析的成年终末期肾病（ESRD）患者。主要结局将是手术前后的HAT值（在桡动脉、尺动脉和四条手部动脉处测量）。次要结局将包括HAIDI的发生率、血管通路通畅率和并发症发生率。需要126名受试者的样本量来估计HAIDI发生率，置信区间为95%，精度为±5%。统计分析将包括配对t检验，以比较术前和术后的HAT值，并确定诊断HAIDI的最佳HAT临界值。
本研究已获得贝尔维奇大学医院机构审查委员会的批准（PR 201/23）。在进行任何与研究相关的程序之前，将从所有研究参与者处获得书面知情同意书。研究结果将发表在同行评审期刊上。
ClinicalTrial.gov：NCT06187207。预结果。
