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在重症监护病房中对接受急性肾脏替代治疗的危重症成人进行神经认知结局和脑氧合评估:INCOGNITO-AKI 研究方案。

Identifying neurocognitive outcomes and cerebral oxygenation in critically ill adults on acute kidney replacement therapy in the intensive care unit: the INCOGNITO-AKI study protocol.

机构信息

Centre for Neuroscience Studies, Queen's University, Kingston, Ontario, Canada.

Department of Medicine, Queen's University, Kingston, Ontario, Canada.

出版信息

BMJ Open. 2021 Aug 17;11(8):e049250. doi: 10.1136/bmjopen-2021-049250.

Abstract

INTRODUCTION

Initiation of acute kidney replacement therapy (KRT) is common in critically ill adults admitted to the intensive care unit (ICU), and associated with increased morbidity and mortality. KRT has been linked to poor neurocognitive outcomes, leading to reduced quality of life and increased utilisation of healthcare resources. Adults on dialysis in the ICU may be particularly at risk of neurocognitive impairment, as survivors of critical illness are already predisposed to developing cerebrovascular disease and cognitive dysfunction long-term relative to healthy controls. Regional cerebral oxygen saturation may provide a critical early marker of long-term neurocognitive impairment in this population. This study aims to understand cerebral oxygenation in patients undergoing KRT (continuous or intermittent) in the ICU. These findings will be correlated with long-term cognitive and functional outcomes, and structural brain pathology.

METHODS AND ANALYSIS

108 patients scheduled to undergo treatment for acute kidney injury with KRT in the Kingston Health Sciences Centre ICU will be recruited into this prospective observational study. Enrolled patients will be assessed with intradialytic cerebral oximetry using near infrared spectroscopy. Delirium will be assessed daily with the Confusion Assessment Method-ICU (CAM-ICU) and severity quantified as cumulative CAM-ICU-7 scores. Neurocognitive impairment will be assessed at 3 and 12 months after hospital discharge using the Kinarm and Repeatable Battery for the Assessment of Neuropsychological Status. Structural brain pathology on MRI will also be measured at the same timepoints. Driving safety, adverse events and medication adherence will be assessed at 12 months to evaluate the impact of neurocognitive impairment on functional outcomes.

ETHICS AND DISSEMINATION

This study is approved by the Queen's University Health Sciences/Affiliated Teaching Hospitals Research Ethics Board (DMED-2424-20). Results will be presented at critical care conferences, and a lay summary will be provided to patients in their preferred format.

TRIAL REGISTRATION NUMBER

NCT04722939.

摘要

介绍

危重症成人患者在重症监护病房(ICU)中经常开始接受急性肾脏替代治疗(KRT),且这与发病率和死亡率的增加有关。KRT 与不良神经认知结局相关,导致生活质量降低和医疗保健资源利用增加。在 ICU 中接受透析的成年人可能特别容易出现神经认知障碍,因为危重症幸存者与健康对照组相比,已经有发生脑血管疾病和认知功能障碍的长期倾向。区域性脑氧饱和度可能为该人群的长期神经认知障碍提供关键的早期标志物。本研究旨在了解 ICU 中接受 KRT(连续或间歇性)治疗的患者的脑氧合情况。这些发现将与长期认知和功能结局以及结构脑病理学相关联。

方法和分析

将从金士顿健康科学中心 ICU 计划接受 KRT 治疗急性肾损伤的 108 名患者招募到这项前瞻性观察性研究中。入组患者将使用近红外光谱法进行透析期间脑氧饱和度评估。使用 ICU 意识模糊评估法(CAM-ICU)每天评估谵妄,并通过累积 CAM-ICU-7 评分量化严重程度。出院后 3 个月和 12 个月,使用 Kinarm 和重复神经心理状态评估量表(Repeatable Battery for the Assessment of Neuropsychological Status,RBANS)评估神经认知障碍。在相同时间点还将测量 MRI 上的结构脑病理学。在 12 个月时评估驾驶安全性、不良事件和药物依从性,以评估神经认知障碍对功能结局的影响。

伦理和传播

本研究已获得皇后大学健康科学/附属医院研究伦理委员会(DMED-2424-20)的批准。研究结果将在重症监护会议上进行报告,并以患者首选的格式向其提供通俗易懂的总结。

试验注册编号

NCT04722939。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2f83/8372874/8f3929d94d59/bmjopen-2021-049250f01.jpg

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