Clinical and Translational Research Accelerator, Yale School of Medicine, New Haven, Connecticut, USA.
Section of Nephrology, Department of Internal Medicine, Yale New Haven Hospital, New Haven, Connecticut, USA.
BMJ Open. 2023 Apr 17;13(4):e071968. doi: 10.1136/bmjopen-2023-071968.
Although studies have examined the utility of clinical decision support tools in improving acute kidney injury (AKI) outcomes, no study has evaluated the effect of real-time, personalised AKI recommendations. This study aims to assess the impact of individualised AKI-specific recommendations delivered by trained clinicians and pharmacists immediately after AKI detection in hospitalised patients.
KAT-AKI is a multicentre randomised investigator-blinded trial being conducted across eight hospitals at two major US hospital systems planning to enrol 4000 patients over 3 years (between 1 November 2021 and 1 November 2024). A real-time electronic AKI alert system informs a dedicated team composed of a physician and pharmacist who independently review the chart in real time, screen for eligibility and provide combined recommendations across the following domains: diagnostics, volume, potassium, acid-base and medications. Recommendations are delivered to the primary team in the alert arm or logged for future analysis in the usual care arm. The planned primary outcome is a composite of AKI progression, dialysis and mortality within 14 days from randomisation. A key secondary outcome is the percentage of recommendations implemented by the primary team within 24 hours from randomisation. The study has enrolled 500 individuals over 8.5 months. Two-thirds were on a medical floor at the time of the alert and 17.8% were in an intensive care unit. Virtually all participants were recommended for at least one diagnostic intervention. More than half (51.6%) had recommendations to discontinue or dose-adjust a medication. The median time from AKI alert to randomisation was 28 (IQR 15.8-51.5) min.
The study was approved by the ethics committee of each study site (Yale University and Johns Hopkins institutional review board (IRB) and a central IRB (BRANY, Biomedical Research Alliance of New York). We are committed to open dissemination of the data through clinicaltrials.gov and sharing of data on an open repository as well as publication in a peer-reviewed journal on completion.
NCT04040296.
尽管已有研究探讨了临床决策支持工具在改善急性肾损伤（AKI）结局方面的效用，但尚无研究评估实时、个性化 AKI 推荐的效果。本研究旨在评估在住院患者中发现 AKI 后，由经过培训的临床医生和药剂师提供的个体化 AKI 特定建议对 AKI 检测的即时影响。
KAT-AKI 是一项多中心、随机、研究者设盲试验，正在美国两大医疗系统的八家医院进行，计划在 3 年内招募 4000 名患者（2021 年 11 月 1 日至 2024 年 11 月 1 日）。实时电子 AKI 警报系统通知由一名医生和一名药剂师组成的专门团队，他们会实时独立查看图表、筛选合格人员，并在以下领域提供联合建议：诊断、容量、钾、酸碱和药物。建议会传递给警报组的主要团队，或在常规护理组中记录以备将来分析。计划的主要结局是在随机分组后 14 天内 AKI 进展、透析和死亡的复合结局。关键次要结局是随机分组后 24 小时内主要团队实施建议的百分比。该研究已在 8.5 个月内招募了 500 名参与者。三分之二的人在发出警报时在医疗楼层，17.8%的人在重症监护病房。几乎所有参与者都至少被推荐进行一项诊断干预。超过一半（51.6%）的人被建议停止或调整药物剂量。从 AKI 警报到随机分组的中位时间为 28 分钟（IQR 15.8-51.5）。
该研究已获得每个研究地点的伦理委员会的批准（耶鲁大学和约翰霍普金斯机构审查委员会（IRB）和一个中央 IRB（BRANY，纽约生物医学研究联盟）。我们致力于通过 clinicaltrials.gov 公开传播数据，并在完成后在开放存储库中共享数据以及在同行评议期刊上发表。
NCT04040296。
