Can a Sick-Day Protocol to Improve Outcomes in Chronic Kidney Disease?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 342
- 试验地点
- 2
- 主要终点
- Change in Renal Function From Baseline to Study Completion;
研究概览
简要总结
The benefits of renin angiotensin system (RAS) blockers and diuretics for blood pressure control are well-established in chronic kidney diseases (CKD) patients; however, these agents may become hazardous on "sick-days" that lead to volume depletion (dehydration), and increase the risk of kidney function loss and acute kidney injury (AKI). It is not known how frequent significant sick-days occur in CKD patients, or whether a patient self-managed Sick-Day Protocol (SDP) that temporarily holds RAS blocker, diuretics, or other high risk medication in an effort to preserve renal function, or prevent AKI. The purpose of the study is to asses if a SDP, monitored remotely with a weekly automated phone survey , can improve outcomes in CKD (such as slow renal function loss and AKI episodes) and reduce preventable service utilization versus usual care.
详细描述
Hypothesis: implementing a self managed "Sick-Day Protocol" with telephone monitoring via interactive voice survey dial-response system (IVSDRS) in CKD patients taking RAS blockers, diuretics, metformin, or NSAIDs, will safely slow renal function loss, reduce the incidence of acute kidney injury, and prevent urgent health utilization; in comparison to usual care.
Study Design: 6-month randomized trial of Sick-Day Protocol vs usual care
Randomization: In-block randomization stratified by use (with or without any other qualifying medication) vs non-use of RAS blocker (with any other qualifying medication)
Intervention: Sick-Day Protocol (instructions for holding and resumption of certain medicines in the event of dehydrating illness), IVRSDRS remote monitoring, augmented laboratory monitoring, and decision support from the VA Renal Inter-disciplinary Safety clinic (RISC)
Study Population: Veterans across the VA Maryland Health Care System (VAMCHS) with a current prescription for any type of RAS blocker, Diuretic, Metformin or NSAID.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Veterans with prescription for any type of RAS blocker, diuretic, Metformin or NSAID
排除标准
- •Expected death or dialysis within 6 months
- •No home or cellular telephone
结局指标
主要结局
Change in Renal Function From Baseline to Study Completion;
时间窗: 6 months (enrollment to study completion)
Laboratory measurement of creatinine at study entry and completion
次要结局
- ER Use and Hospitalization(6 months (enrollment to study completion))
- Acute Kidney Injury Incidents(6 months (enrollment to study completion))
研究者
Jeffrey Fink
Division Head, General Internal Medicine
University of Maryland, Baltimore