BMJ open · 2025
Hand acceleration time (HAT) as a diagnostic tool in the assessment of haemodialysis access-induced distal ischaemia (HAIDI): study protocol for a prospective cohort study in the Barcelona south metropolitan area.
СтатьяПротокол клинического исследованияНазвание и аннотация: Перевод в очереди
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Gonzalo Begoña, Videla Sebastian, Espinar Emma, Palacios Siloé, Herranz Carolina, Iborra Ortega Elena
Аннотация
INTRODUCTION: 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.
METHODS AND ANALYSIS: 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.
ETHICS AND DISSEMINATION: 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.
TRIAL REGISTRATION NUMBER: ClinicalTrial.gov: NCT06187207. Pre Results.
METHODS AND ANALYSIS: 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.
ETHICS AND DISSEMINATION: 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.
TRIAL REGISTRATION NUMBER: ClinicalTrial.gov: NCT06187207. Pre Results.