Can a sick-day protocol improve outcomes in Chronic Kidney Disease?

肾素血管紧张素系统(RAS)阻滞剂和利尿剂对CKD患者的益处是确凿的； 然而，这些药剂可能在“病假”时变得危险，从而导致容量消耗和增加 肾功能丧失和急性肾损伤(AKI)的风险。目前尚不清楚重大病假的频率有多高 发生在CKD患者中，或者是临时控制RAS的自我管理病假方案(SDP) 阻滞剂和利尿剂在保护肾功能或预防AKI方面是安全或有效的。假设：一种自我 CKD患者经管理的SDP将安全地减少肾功能损失、AKI事件和可预防的服务 利用率。研究设计：为期6个月的实用型随机试验。研究人群：III-V期，透析前 CKD患者，根据RAS阻滞剂和环状利尿剂的治疗被认为是高危患者。研究地点：弗吉尼亚州 马里兰州医疗保健系统(VAMHCS)，包括两家医院和城乡门诊网络 诊所。干预：干预参与者将获得每月一次的SDP说明 通过交互式语音调查拨号响应系统(IVSDRS)进行监测，以跟踪病假频率和 对这些事件的自我管理反应。将对日常护理参与者进行教育，使其了解 请病假，并鼓励在病假发生时致电医疗服务提供者寻求治疗指导。所有参与者 会被要求在生病时获得肾功能的测量结果。具体目标：1)比较安全和 SDP干预与常规护理的有效性。2)确定年内病假发生率 使用远程IVSDRS监测的干预组，并通过对所有参与者的研究结束调查。3)评估 干预ARM参与者使用并遵守远程IVSDRS监控的SDP。学习 测量：基线和6个月肾功能测量，附带肾功能测量 和接近大病假的血液化学，电子健康记录(EHR)审查 AKI(ICD-10代码定义)的住院和发作，大病假和IVSRDS监测 遵守SDP。结果：6个月内肾功能的变化，ICD-10定义的AKI的发生率， 门诊环境中血肌酐定义的AKI的频率，病假事件的IVSDRS检测， 和干预ARM参与者停止和及时恢复RAS阻滞剂和/或利尿剂， 分析方案：肾功能改变干预与常规护理参与者的比较 使用广义线性模型和泊松回归方法计算急性心肌梗死和住院的频率， 分别进行了分析。将使用类似的回归方法来确定调整后的病假频率比率 事件和参与者对病假的反应。预期结果：在高风险人群中使用自我管理的SDP CKD患者在有初步证据保护肾功能的情况下可以安全地给予治疗，并且 预防AKI。

The benefits to CKD patients of renin angiotensin system (RAS) blockers and diuretics are well-established; however, these agents may become hazardous on “sick-days” that lead to volume depletion and increase the risk of renal function loss and acute kidney injury (AKI). It is not known how frequent significant sick-days occur in CKD patients, or whether a self-managed sick-day protocol (SDP) that temporarily holds RAS blocker and diuretics is safe or effective in preserving renal function, or preventing AKI. Hypothesis: a self- managed SDP in CKD patients will safely reduce renal function loss, AKI episodes and preventable service utilization. Study Design: 6-month pragmatic randomized trial. Study population: Stage III-V, pre-dialysis CKD patients, deemed high-risk based on treatment with a RAS blocker and loop diuretic. Study site: VA Maryland Health Care System (VAMHCS) including a network of two hospitals, and urban and rural outpatient clinics. Intervention: Intervention participants will be provided with instructions for an SDP with monthly monitoring via an interactive voice-survey dial-response system (IVSDRS) to track frequency of sick-days and self-management responses to these incidents. Usual care participants will be educated on the significance of sick-days and encouraged to call providers for guidance on therapy when sick-days occur. All participants will be asked to obtain measures of renal function when sick. Specific aims: 1) Compare the safety and effectiveness of the SDP intervention versus usual care. 2) Determine the incidence of sick-days in the intervention arm using remote IVSDRS monitoring and by end-of-study survey of all participants. 3) Evaluate intervention arm participants' usage of, and adherence to, the SDP with remote IVSDRS monitoring. Study measurements: Baseline and 6-month measures of renal function, incidental measurement of renal function and blood chemistries proximate to significant sick-days, electronic health record (EHR) review for hospitalizations and episodes of AKI (ICD-10 code-defined), IVSRDS monitoring for significant sick-days and adherence to the SDP. Outcomes: 6-month change in renal function, incidence of ICD-10 defined-AKI, frequency of serum creatinine-defined AKI in the ambulatory setting, IVSDRS detection of sick-day incidents, and intervention arm participants' cessation and timely resumption of RAS blocker and/or diuretics, Analytical plans: Comparison between intervention and usual care participants of renal function change, and frequency of AKI and hospitalization using generalized linear models and Poisson regression methods, respectively. Similar regression methods will be used to determine the adjusted frequency rate of sick-day incidents and participant response to sick-days. Expected findings: Use of a self-managed SDP in high-risk CKD patients is feasible to safely administer with preliminary evidence for preservation of renal function, and prevention of AKI.