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

RATIONALE & 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....

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Autores principales: Fink, Jeffrey C., Maguire, Rebecca M., Blakeman, Thomas, Tomlinson, Laurie A., Tomson, Charles, Wagner, Lee-Ann, Zhan, Min
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Elsevier 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9421397/
https://www.ncbi.nlm.nih.gov/pubmed/36046613
http://dx.doi.org/10.1016/j.xkme.2022.100527
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author Fink, Jeffrey C.
Maguire, Rebecca M.
Blakeman, Thomas
Tomlinson, Laurie A.
Tomson, Charles
Wagner, Lee-Ann
Zhan, Min
author_facet Fink, Jeffrey C.
Maguire, Rebecca M.
Blakeman, Thomas
Tomlinson, Laurie A.
Tomson, Charles
Wagner, Lee-Ann
Zhan, Min
author_sort Fink, Jeffrey C.
collection PubMed
description RATIONALE & 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 m(2), 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. TRIAL REGISTRATION: ClinicalTrials.gov; NCT03141905.
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spelling pubmed-94213972022-08-30 Medication Holds in CKD During Acute Volume-Depleting Illnesses: A Randomized Controlled Trial of a “Sick-Day” Protocol Fink, Jeffrey C. Maguire, Rebecca M. Blakeman, Thomas Tomlinson, Laurie A. Tomson, Charles Wagner, Lee-Ann Zhan, Min Kidney Med Original Research RATIONALE & 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 m(2), 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. TRIAL REGISTRATION: ClinicalTrials.gov; NCT03141905. Elsevier 2022-07-31 /pmc/articles/PMC9421397/ /pubmed/36046613 http://dx.doi.org/10.1016/j.xkme.2022.100527 Text en © 2022 The Authors https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
spellingShingle Original Research
Fink, Jeffrey C.
Maguire, Rebecca M.
Blakeman, Thomas
Tomlinson, Laurie A.
Tomson, Charles
Wagner, Lee-Ann
Zhan, Min
Medication Holds in CKD During Acute Volume-Depleting Illnesses: A Randomized Controlled Trial of a “Sick-Day” Protocol
title Medication Holds in CKD During Acute Volume-Depleting Illnesses: A Randomized Controlled Trial of a “Sick-Day” Protocol
title_full Medication Holds in CKD During Acute Volume-Depleting Illnesses: A Randomized Controlled Trial of a “Sick-Day” Protocol
title_fullStr Medication Holds in CKD During Acute Volume-Depleting Illnesses: A Randomized Controlled Trial of a “Sick-Day” Protocol
title_full_unstemmed Medication Holds in CKD During Acute Volume-Depleting Illnesses: A Randomized Controlled Trial of a “Sick-Day” Protocol
title_short Medication Holds in CKD During Acute Volume-Depleting Illnesses: A Randomized Controlled Trial of a “Sick-Day” Protocol
title_sort medication holds in ckd during acute volume-depleting illnesses: a randomized controlled trial of a “sick-day” protocol
topic Original Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9421397/
https://www.ncbi.nlm.nih.gov/pubmed/36046613
http://dx.doi.org/10.1016/j.xkme.2022.100527
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