Medication Holds in CKD During Acute Volume-Depleting Illnesses: A Randomized Controlled Trial of a "Sick-Day" Protocol.
Medication Holds in CKD During Acute Volume-Depleting Illnesses: A Randomized Controlled Trial of a "Sick-Day" Protocol.
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DOI：
10.1016/j.xkme.2022.100527
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发表时间：
2022-09
期刊：
影响因子：
3.9
通讯作者：
Zhan, Min
中科院分区：
文献类型：
--
作者：
Fink, Jeffrey C;Maguire, Rebecca M;Blakeman, Thomas;Tomlinson, Laurie A;Tomson, Charles;Wagner, Lee-Ann;Zhan, Min
某些慢性肾脏病（CKD）处方药可能会因增加急性肾损伤（阿基）和肾功能丧失的风险而在容量不足的病假中变得危险;然而，在并发疾病期间使用这些药物的风险和益处尚不清楚。6-一项为期一个月的实用性试验，检查病假方案，以确定在容量消耗性疾病期间暂停预先指定的药物是否会降低CKD中阿基或肾功能丧失的发生率。315名患有3-5期CKD的退伍军人，接受了肾素-血管紧张素-醛固酮抑制剂阻滞剂、利尿剂、非甾体抗炎药或二甲双胍治疗，随机分为病假方案组和常规护理组，分别为n = 159和n = 156。通过交互式语音应答系统（IVRS）或常规护理管理病假方案，随访6个月。研究结果如下：（1）肾功能变化，（2）基于国际疾病分类第十版编码和门诊实验室检测的阿基发生率，（3）紧急服务利用率，（4）病假。平均年龄为70.1 ± 7.4岁和69.2 ± 8.1岁，平均基线肾小球滤过率（GFR）为43.1 ± 13.1和43.8 ± 13.0 mL/min/1.73 m2，病假方案和常规护理组分别有112（70%）和100（64%）例糖尿病受试者。从基线到6个月随访，病假方案组和常规护理组的GFR平均变化分别为-0.71（95%CI，-2.11至0.69）和-0.72（95%CI，-2.12至0.68），无显著差异，P = 0.99。病假方案组和常规护理组的住院率分别为11.5/100和8.4/100例事件/人月，调整后的率比未显著增加（患病率比，1.30; 95%CI，0.96-1.76）。参与者在81%的预期周内与IVRS互动，19人有一个或多个合格事件。在33个真正的病假中，参与者仅在14天内正确遵守了协议。研究6个月期间病假发生率低。在高危CKD人群中，病假方案与阿基发作或肾功能丧失的显著减少无关。对IVRS的参与度很高，但病假协议的成功实施并非最佳。ClinicalTrials.gov; NCT03141905.
Some drugs prescribed for chronic kidney disease (CKD) may become hazardous on sick days with volume depletion by increasing the risk of acute kidney injury (AKI) and kidney function loss; however, the risks and benefits of their use during intercurrent illness is unknown. 6-month pragmatic trial examining a sick-day protocol to determine if withholding prespecified drugs during a volume-depleting illness reduces the incidence AKI or kidney function loss in CKD. 315 veterans with stage 3-5 CKD, treated with a renin-angiotensin-aldosterone inhibitor blocker, diuretic, nonsteroidal anti-inflammatory drug, or metformin were randomized into the study with n = 159 and n = 156 in sick-day protocol and usual care groups, respectively. Sick-day protocol administered via interactive voice response system (IVRS) or usual care with 6-month follow-up. The outcomes of the study are as follows: (1) Change in kidney function, (2) incidence of AKI based on International Classification of Diseases, Tenth Revision codes and ambulatory laboratory testing, (3) urgent service utilizations, and (4) sick days. The mean age was 70.1 ± 7.4 and 69.2 ± 8.1 years, with a mean baseline glomerular filtration rate (GFR) of 43.1 ± 13.1 and 43.8 ± 13.0 mL/min/1.73 m2, and 112 (70%) and 100 (64%) of participants with diabetes in the sick-day protocol and usual care groups, respectively. The mean change in GFR in the sick-day protocol and usual care groups from baseline to 6-month follow-up, adjusting for baseline GFR, was −0.71 (95% CI, −2.11 to 0.69) and −0.72 (95% CI, −2.12 to 0.68), respectively, with no significant difference, P = 0.99. Hospitalizations in the sick-day protocol and usual care groups were 11.5/100 and 8.4/100 events per person-months, respectively, with the adjusted rate ratio not significantly increased (prevalence ratio, 1.30; 95% CI, 0.96-1.76). Participants interacted with the IVRS in 81% of expected weeks and 19 had one or more qualifying events. In 33 true sick days, participants correctly followed the protocol in only 14. Low incidence of sick days over the 6-month period of the study. The sick-day protocol was not associated with a significant reduction in AKI episodes or kidney function loss in a high-risk CKD population. Engagement with the IVRS was high, but successful implementation of the sick-day protocol was not optimal. ClinicalTrials.gov; NCT03141905.