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在南非一家农村三级教学医院的重症监护病房患者中开发和验证急性肾损伤的临床预测模型:研究方案。

Development and validation of a clinical prediction model of acute kidney injury in intensive care unit patients at a rural tertiary teaching hospital in South Africa: a study protocol.

机构信息

Anaesthesiology and Critcal Care, Walter Sisulu University, Mthatha, Eastern Cape, South Africa

Department of Critical Care, University of Pretoria, Pretoria, Gauteng, South Africa.

出版信息

BMJ Open. 2022 Jul 27;12(7):e060788. doi: 10.1136/bmjopen-2022-060788.

Abstract

INTRODUCTION

Acute kidney injury (AKI) is a decline in renal function lasting hours to days. The rising global incidence of AKI, and associated costs of renal replacement therapy, is a public health priority. With the only therapeutic option being supportive therapy, prevention and early diagnosis will facilitate timely interventions to prevent progression to chronic kidney disease. While many factors have been identified as predictive of AKI, none have shown adequate sensitivity or specificity on their own. Many tools have been developed in developed-country cohorts with higher rates of non-communicable disease, and few have been validated and practically implemented. The development and validation of a predictive tool incorporating clinical, biochemical and imaging parameters, as well as quantification of their impact on the development of AKI, should make timely and improved prediction of AKI possible. This study is positioned to develop and validate an AKI prediction tool in critically ill patients at a rural tertiary hospital in South Africa.

METHOD AND ANALYSIS

Critically ill patients will be followed from admission until discharge or death. Risk factors for AKI will be identified and their impact quantified using statistical modelling. Internal validation of the developed model will be done on separate patients admitted at a different time. Furthermore, patients developing AKI will be monitored for 3 months to assess renal recovery and quality of life. The study will also explore the utility of endothelial monitoring using the biomarker Syndecan-1 and capillary leak measurements in predicting persistent AKI.

ETHICS AND DISSEMINATION

The study has been approved by the Walter Sisulu University Faculty of Health Science Research Ethics and Biosafety Committee (WSU No. 005/2021), and the Eastern Cape Department of Health Research Ethics (approval number: EC 202103006). The findings will be shared with facility management, and presented at relevant conferences and seminars.

摘要

简介

急性肾损伤(AKI)是指肾功能在数小时至数天内下降。AKI 的全球发病率不断上升,肾脏替代治疗的相关费用是一个公共卫生重点。由于唯一的治疗选择是支持性治疗,因此预防和早期诊断将有助于及时干预,以防止其进展为慢性肾脏病。虽然已经确定了许多因素可预测 AKI,但它们本身的敏感性或特异性都不足。许多工具是在非传染性疾病发病率较高的发达国家队列中开发的,而在发展中国家,这些工具很少得到验证和实际应用。开发和验证一种包含临床、生化和影像学参数的预测工具,并对其对 AKI 发展的影响进行量化,应该可以使 AKI 的及时和改善预测成为可能。本研究旨在开发和验证南非农村三级医院危重症患者的 AKI 预测工具。

方法与分析

危重症患者将从入院开始一直随访至出院或死亡。将确定 AKI 的危险因素,并使用统计模型对其影响进行量化。在不同时间入院的其他患者中对开发的模型进行内部验证。此外,将对发生 AKI 的患者进行 3 个月的监测,以评估肾功能恢复和生活质量。该研究还将探索使用生物标志物 Syndecan-1 和毛细血管渗漏测量值进行内皮监测在预测持续性 AKI 中的效用。

伦理与传播

该研究已获得 Walter Sisulu 大学健康科学研究伦理和生物安全委员会(WSU No. 005/2021)和东开普省卫生部研究伦理委员会(批准号:EC 202103006)的批准。研究结果将与医疗机构共享,并在相关会议和研讨会上进行介绍。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4099/9335058/3d21fac2d789/bmjopen-2022-060788f01.jpg

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