Medication Holds in CKD During Acute Volume-Depleting Illnesses: A Randomized Controlled Trial of a "Sick-Day" Protocol.
AuthorFink, Jeffrey C
Maguire, Rebecca M
Tomlinson, Laurie A
MetadataShow full item record
AbstractRationale & objective: 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. Study design: 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. Setting & participants: 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. Intervention: Sick-day protocol administered via interactive voice response system (IVRS) or usual care with 6-month follow-up. Outcomes: 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. Results: 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. Limitations: Low incidence of sick days over the 6-month period of the study. Conclusions: 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.
Rights/Terms© 2022 The Authors.
Identifier to cite or link to this itemhttp://hdl.handle.net/10713/19668
- Safety and Efficacy of Imatinib for Hospitalized Adults with COVID-19: A structured summary of a study protocol for a randomised controlled trial.
- Authors: Emadi A, Chua JV, Talwani R, Bentzen SM, Baddley J
- Issue date: 2020 Oct 28
- Canagliflozin and Kidney-Related Adverse Events in Type 2 Diabetes and CKD: Findings From the Randomized CREDENCE Trial.
- Authors: Heerspink HJL, Oshima M, Zhang H, Li J, Agarwal R, Capuano G, Charytan DM, Craig J, de Zeeuw D, Di Tanna GL, Levin A, Neal B, Perkovic V, Wheeler DC, Yavin Y, Jardine MJ
- Issue date: 2022 Feb
- What are the risks and benefits of temporarily discontinuing medications to prevent acute kidney injury? A systematic review and meta-analysis.
- Authors: Whiting P, Morden A, Tomlinson LA, Caskey F, Blakeman T, Tomson C, Stone T, Richards A, Savović J, Horwood J
- Issue date: 2017 Apr 7
- Virtualized clinical studies to assess the natural history and impact of gut microbiome modulation in non-hospitalized patients with mild to moderate COVID-19 a randomized, open-label, prospective study with a parallel group study evaluating the physiologic effects of KB109 on gut microbiota structure and function: a structured summary of a study protocol for a randomized controlled study.
- Authors: Haran JP, Pinero JC, Zheng Y, Palma NA, Wingertzahn M
- Issue date: 2021 Apr 2
- Screening for CKD To Improve Processes of Care among Nondiabetic Veterans with Hypertension: A Pragmatic Cluster-Randomized Trial.
- Authors: Peralta CA, Frigaard M, Rolon L, Seal K, Tuot D, Senyak J, Lo L, Powe N, Scherzer R, Chao S, Chiao P, Lui K, Shlipak MG, Rubinsky AD
- Issue date: 2020 Feb 7