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

病假方案可以改善慢性肾脏病的治疗结果吗？

• 批准号: 9339683
• 负责人: JEFFREY C FINK
• 金额: $ 28.35万
• 依托单位: UNIVERSITY OF MARYLAND BALTIMORE
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-09-01 至 2020-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9339683
• 关键词: Acute Renal Failure with Renal Papillary Necrosis; Adherence; Ambulatory Care Facilities; Biological Preservation; Blood Chemical Analysis; Caring; Chronic Kidney Failure; Clinical; Code; Communities; Computerized Medical Record; Consensus; Consent; Creatinine; Detection; Dialysis procedure; Diuretics; Effectiveness; Electrolytes; Electronic Health Record; Emergency department visit; Enrollment; Evaluation; Event; Frequencies; Guidelines; Healthcare Systems; Hospitalization; Hospitals; Hypotension; Illness Days; Incidence; Instruction; International Statistical Classification of Diseases and Related Health Problems, Tenth Revision (ICD-10); Intervention; Kidney; Kidney Diseases; Lead; Linear Models; Maryland; Measurement; Measures; Methods; Modification; Monitor; National Health Services; Outcome; Participant; Patient Monitoring; Patients; Population; Prevention; Protocols documentation; Provider; Randomized; Renal function; Renin-Angiotensin System; Research Design; Resolution; Risk; Rural; Safety; Self Management; Serum; Site; Surveys; System; Telephone; Testing; Time; Translational Research; Visit; Voice; arm; base; blood pressure regulation; design; experience; hazard; health service use; high risk; improved outcome; loss of function; novel; pragmatic trial; prevent; programs; randomized trial; response; service utilization; study population; treatment as usual; trial comparing; virtual laboratory

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.

肾素血管紧张素系统（RAS）阻滞剂和利尿剂对CKD患者的益处是公认的；

项目成果

Medication Holds in CKD During Acute Volume-Depleting Illnesses: A Randomized Controlled Trial of a "Sick-Day" Protocol.

• DOI: 10.1016/j.xkme.2022.100527
• 发表时间: 2022-09
• 期刊: KIDNEY MEDICINE
• 影响因子: 3.9
• 作者: Fink, Jeffrey C;Maguire, Rebecca M;Blakeman, Thomas;Tomlinson, Laurie A;Tomson, Charles;Wagner, Lee-Ann;Zhan, Min
• 通讯作者: Zhan, Min