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超声(SONAR)引导下监测动静脉内瘘用于血液透析患者:一项多中心观察性研究的研究方案。

Surveillance arterioveNous fistulAs using ultRasound (SONAR) trial in haemodialysis patients: a study protocol for a multicentre observational study.

机构信息

Department of Surgery, Addenbrooke's Hospital, Cambridge, UK.

Department of Surgery, Cambridge University, Cambridge, UK.

出版信息

BMJ Open. 2019 Jul 23;9(7):e031210. doi: 10.1136/bmjopen-2019-031210.

Abstract

INTRODUCTION

Arteriovenous fistulas (AVFs) are considered the best and safest modality for providing haemodialysis in patients with end-stage renal disease. Only 20% of UK centres achieve the recommended 80% target for achieving dialysis of the prevalent dialysis population via permanent access (as opposed to a central venous catheter). This is partly due to the relatively poor maturation rate of newly created fistulas, with as many as 50% of fistulas failing to mature.The Surveillance Of arterioveNous fistulAe using ultRasound study will examine whether a protocolised programme of Doppler ultrasound (US) surveillance can identify, early after creation, potentially correctable problems in those AVFs that subsequently fail to mature.

METHODS AND ANALYSIS

This is a multicentre observational study that will assess newly created AVFs by Doppler US performed at 2, 4, 6 and 10 weeks after creation. The primary outcome measure will be primary fistula patency at week 10. Secondary outcome measures include: successful use of the fistula; clinical suitability for dialysis; creation of new fistula or radiological salvage; fistula thrombosis; secondary fistula patency rate and patient acceptability.

ETHICS AND DISSEMINATION

The study has been approved by the Cambridgeshire and Hertfordshire Research Ethics Committee and by the Health Research Authority (REC 18/EE/0234). The results generated from this work will be published as open access, within 3 years of trial commencement. We will also present our findings at key national/international renal meetings, as well as support volunteers at renal patient groups to disseminate the trial outcome.

TRIAL REGISTRATION NUMBER

ISRCTN36033877.

摘要

简介

动静脉瘘(AVF)被认为是为终末期肾病患者提供血液透析的最佳和最安全的方式。只有 20%的英国中心通过永久性通路(而不是中央静脉导管)实现了为流行透析人群进行透析的建议 80%目标。这在一定程度上是由于新创建的瘘管成熟率相对较低,多达 50%的瘘管未能成熟。超声监测动静脉瘘研究将检查超声(US)监测的规范化方案是否可以在那些随后未能成熟的 AVF 中,在创建后早期识别潜在可纠正的问题。

方法和分析

这是一项多中心观察性研究,将通过多普勒 US 在创建后 2、4、6 和 10 周评估新创建的 AVF。主要结局指标将是第 10 周时的原发性瘘管通畅率。次要结局指标包括:瘘管的成功使用;用于透析的临床适宜性;新瘘管的创建或放射学抢救;瘘管血栓形成;继发性瘘管通畅率和患者可接受性。

伦理和传播

该研究已获得剑桥郡和赫特福德郡研究伦理委员会以及卫生研究管理局(REC 18/EE/0234)的批准。该工作产生的结果将在 3 年内以开放获取的形式发布。我们还将在重要的国家/国际肾脏会议上介绍我们的发现,并支持肾脏患者团体的志愿者传播试验结果。

试验注册号

ISRCTN36033877。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3617/6661628/559925ef328b/bmjopen-2019-031210f01.jpg

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