Timing of Antihypertensive Medications on Key Outcomes in Hemodialysis: A Cluster Randomized Trial.
blood pressure
clinical trial
dialysis
end stage kidney disease
hemodialysis
Journal
Kidney360
ISSN: 2641-7650
Titre abrégé: Kidney360
Pays: United States
ID NLM: 101766381
Informations de publication
Date de publication:
25 11 2021
25 11 2021
Historique:
received:
19
03
2021
accepted:
30
08
2021
entrez:
4
4
2022
pubmed:
5
4
2022
medline:
8
4
2022
Statut:
epublish
Résumé
We conducted this study to examine the effect of taking versus holding BP medications before hemodialysis on intradialytic hypotension (IDH). In this cluster randomized trial, each dialysis unit was randomly designated as TAKE or HOLD units. Participants within a TAKE unit were instructed to take all BP medications as prescribed, whereas participants within a HOLD unit were instructed to hold medications dosed more than once daily before hemodialysis. The intervention lasted for 4 weeks. We hypothesized that TAKE would be noninferior to HOLD on the primary outcome of asymptomatic IDH, defined as ≥30% of sessions with nadir systolic BP <90 mm Hg and on the following secondary outcomes: uncontrolled hypertension (predialysis systolic BP >160 mm Hg), failure to achieve dry weight, and shortened dialysis sessions. We randomized 10 dialysis units in a 1:1 ratio to TAKE or HOLD, which included 65 participants in TAKE and 66 participants in HOLD. We did not show that TAKE was noninferior to HOLD for the primary IDH outcome (mean unadjusted difference of 8%; 95% CI, -3% to 19%). TAKE was superior to HOLD for the outcome of uncontrolled hypertension (mean unadjusted difference of -15%, 95% CI, -28% to -1%). TAKE was noninferior to HOLD for the outcomes of failure to achieve dry weight and shortened dialysis sessions. In this cluster randomized trial that randomized patients to either taking or holding BP medications before hemodialysis, a strategy of taking BP medications dosed more than once daily was not noninferior to holding BP medications for the primary outcome of IDH, but did reduce the occurrence of uncontrolled hypertension. Whether any potential benefit of holding BP medications on reducing IDH is offset by any potential harm related to higher predialysis BP remains to be seen.
Sections du résumé
Background
We conducted this study to examine the effect of taking versus holding BP medications before hemodialysis on intradialytic hypotension (IDH).
Methods
In this cluster randomized trial, each dialysis unit was randomly designated as TAKE or HOLD units. Participants within a TAKE unit were instructed to take all BP medications as prescribed, whereas participants within a HOLD unit were instructed to hold medications dosed more than once daily before hemodialysis. The intervention lasted for 4 weeks. We hypothesized that TAKE would be noninferior to HOLD on the primary outcome of asymptomatic IDH, defined as ≥30% of sessions with nadir systolic BP <90 mm Hg and on the following secondary outcomes: uncontrolled hypertension (predialysis systolic BP >160 mm Hg), failure to achieve dry weight, and shortened dialysis sessions.
Results
We randomized 10 dialysis units in a 1:1 ratio to TAKE or HOLD, which included 65 participants in TAKE and 66 participants in HOLD. We did not show that TAKE was noninferior to HOLD for the primary IDH outcome (mean unadjusted difference of 8%; 95% CI, -3% to 19%). TAKE was superior to HOLD for the outcome of uncontrolled hypertension (mean unadjusted difference of -15%, 95% CI, -28% to -1%). TAKE was noninferior to HOLD for the outcomes of failure to achieve dry weight and shortened dialysis sessions.
Conclusions
In this cluster randomized trial that randomized patients to either taking or holding BP medications before hemodialysis, a strategy of taking BP medications dosed more than once daily was not noninferior to holding BP medications for the primary outcome of IDH, but did reduce the occurrence of uncontrolled hypertension. Whether any potential benefit of holding BP medications on reducing IDH is offset by any potential harm related to higher predialysis BP remains to be seen.
Identifiants
pubmed: 35373003
doi: 10.34067/KID.0001922021
pii: 02200512-202111000-00011
pmc: PMC8785843
doi:
Substances chimiques
Antihypertensive Agents
0
Banques de données
ClinicalTrials.gov
['NCT03327909']
Types de publication
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
1752-1760Informations de copyright
Copyright © 2021 by the American Society of Nephrology.
Déclaration de conflit d'intérêts
G.M. Chertow reports serving on the Board of Directors for Satellite Healthcare, a nonprofit dialysis provider; reports serving as a consultant to Akebia, Ardelyx, AstraZeneca, Baxter, CloudCath, Cricket, Durect, Gilead, Miromatrix, Outset, Reata, Sanifit, and Vertex; and reports serving on data safety monitoring boards for Angion, Bayer, National Institute of Diabetes and Digestive and Kidney Diseases, and ReCor. T.I. Chang reports receiving funding from Janssen Pharmaceuticals to Stanford University for serving as a national leader for CREDENCE; and reports serving as a consultant for AstraZeneca, Bayer, Fresenius Medical Care, Gilead, Janssen Pharmaceuticals, Novo Nordisk, and Tricida. All remaining authors have nothing to disclose.
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