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肾病学家随访与急性肾损伤住院后的常规护理(FUSION):一项随机对照试验。

Nephrologist Follow-Up versus Usual Care after an Acute Kidney Injury Hospitalization (FUSION): A Randomized Controlled Trial.

机构信息

Division of Nephrology, Kingston Health Sciences Centre, Queen's University, Kingston, Ontario, Canada.

Department of Critical Care Medicine, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada.

出版信息

Clin J Am Soc Nephrol. 2021 Jul;16(7):1005-1014. doi: 10.2215/CJN.17331120. Epub 2021 May 21.

DOI:10.2215/CJN.17331120
PMID:34021031
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8425610/
Abstract

BACKGROUND AND OBJECTIVES

Survivors of AKI are at higher risk of CKD and death, but few patients see a nephrologist after hospital discharge. Our objectives during this 2-year vanguard phase trial were to determine the feasibility of randomizing survivors of AKI to early follow-up with a nephrologist or usual care, and to collect data on care processes and outcomes.

DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: We performed a randomized controlled trial in patients hospitalized with Kidney Disease Improving Global Outcomes (KDIGO) stage 2-3 AKI at four hospitals in Toronto, Canada. We randomized patients to early nephrologist follow-up (standardized basket of care that emphasized BP control, cardiovascular risk reduction, and medication safety) or usual care from July 2015 to June 2017. Feasibility outcomes included the proportion of eligible patients enrolled, seen by a nephrologist, and followed to 1 year. The primary clinical outcome was a major adverse kidney event at 1 year, defined as death, maintenance dialysis, or incident/progressive CKD.

RESULTS

We screened 3687 participants from July 2015 to June 2017, of whom 269 were eligible. We randomized 71 (26%) patients (34 to nephrology follow-up and 37 to usual care). The primary reason stated for declining enrollment included hospitalization-related fatigue (=65), reluctance to add more doctors to the health care team (=59), and long travel times (=40). Nephrologist visits occurred in 24 of 34 (71%) intervention participants, compared with three of 37 (8%) participants randomized to usual care. The primary clinical outcome occurred in 15 of 34 (44%) patients in the nephrologist follow-up arm, and 16 of 37 (43%) patients in the usual care arm (relative risk, 1.02; 95% confidence interval, 0.60 to 1.73).

CONCLUSIONS

Major adverse kidney events are common in AKI survivors, but we found the in-person model of follow-up posed a variety of barriers that was not acceptable to many patients.

CLINICAL TRIAL REGISTRY NAME AND REGISTRATION NUMBER

Nephrologist Follow-up versus Usual Care after an Acute Kidney Injury Hospitalization (FUSION), NCT02483039 CJASN 16: 1005-1014, 2021. doi: https://doi.org/10.2215/CJN.17331120.

摘要

背景与目的

急性肾损伤(AKI)幸存者发生慢性肾脏病(CKD)和死亡的风险较高,但很少有患者在出院后会看肾病医生。在这项为期 2 年的先锋阶段试验中,我们的目标是确定将 AKI 幸存者随机分配到早期与肾病医生随访或常规护理的可行性,并收集护理过程和结局的数据。

设计、地点、参与者和测量方法:我们在加拿大多伦多的四家医院对患有肾脏病改善全球结局(KDIGO)分期 2-3 级 AKI 的住院患者进行了一项随机对照试验。我们将患者随机分为早期肾病医生随访组(强调血压控制、心血管风险降低和药物安全的标准化护理篮)或常规护理组,随访时间为 2015 年 7 月至 2017 年 6 月。可行性结局包括纳入患者的比例、接受肾病医生评估的患者比例以及随访至 1 年的患者比例。主要临床结局为 1 年时的主要不良肾脏事件,定义为死亡、维持性透析或新发/进展性 CKD。

结果

我们于 2015 年 7 月至 2017 年 6 月期间筛查了 3687 名患者,其中 269 名符合条件。我们将 71 名(26%)患者随机分为 34 名(肾病随访组)和 37 名(常规护理组)。拒绝入组的主要原因包括与住院相关的疲劳(=65)、不愿将更多医生加入医疗团队(=59)和长途旅行(=40)。在干预组的 34 名患者中,有 24 名(71%)进行了肾病医生就诊,而在常规护理组的 37 名患者中,仅有 3 名(8%)进行了就诊。在肾病随访组的 34 名患者中,有 15 名(44%)发生了主要不良肾脏事件,而在常规护理组的 37 名患者中,有 16 名(43%)发生了主要不良肾脏事件(相对风险,1.02;95%置信区间,0.60 至 1.73)。

结论

AKI 幸存者的主要不良肾脏事件较为常见,但我们发现,随访的面对面模式给许多患者带来了各种难以接受的障碍。

临床试验注册名称和注册号

急性肾损伤住院后肾病医生随访与常规护理(FUSION),NCT02483039 CJASN 16: 1005-1014, 2021. doi: https://doi.org/10.2215/CJN.17331120.

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5d70/8425610/1dfe195a8d03/CJN.17331120absf1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5d70/8425610/1dfe195a8d03/CJN.17331120absf1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5d70/8425610/1dfe195a8d03/CJN.17331120absf1.jpg

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