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J. Cardiothorac. Vasc. Anesth. · Mar 2022
Randomized Controlled TrialMaintenance of Serum Potassium Levels ≥3.6 mEq/L Versus ≥4.5 mEq/L After Isolated Elective Coronary Artery Bypass Grafting and the Incidence of New-Onset Atrial Fibrillation: Pilot and Feasibility Study Results.
- Niall G Campbell, Elizabeth Allen, Hugh Montgomery, Jon Aron, Ruth R Canter, Matthew Dodd, Julie Sanders, Joanna Sturgess, Diana Elbourne, and Ben O'Brien.
- Division of Cardiovascular Sciences, School of Medical Sciences, Manchester Academic Health Science Centre, University of Manchester, Manchester, United Kingdom; Wythenshawe Hospital, Manchester University Foundation NHS Trust, Manchester, United Kingdom. Electronic address: n.campbell@doctors.org.uk.
- J. Cardiothorac. Vasc. Anesth. 2022 Mar 1; 36 (3): 847-854.
ObjectiveSerum potassium levels frequently are maintained at high levels (≥4.5 mEq/L) to prevent atrial fibrillation after cardiac surgery (AFACS), with limited evidence. Before undertaking a noninferiority randomized controlled trial to investigate the noninferiority of maintaining levels ≥3.6 mEq/L compared with this strategy, the authors wanted to assess the feasibility, acceptability, and safety of recruiting for such a trial.DesignPilot and feasibility study of full trial protocol.SettingTwo university tertiary-care hospitals.ParticipantsA total of 160 individuals undergoing first-time elective isolated coronary artery bypass grafting.InterventionsRandomization (1:1) to protocols aiming to maintain serum potassium at either ≥3.6 mEq/L or ≥4.5 mEq/L after arrival in the postoperative care facility and for 120 hours or until discharge from the hospital or AFACS occurred, whichever happened first.Measurements And Main ResultsPrimary outcomes: (1) whether it was possible to recruit and randomize 160 patients for six months (estimated 20% of those eligible); (2) maintaining supplementation protocol violation rate ≤10% (defined as potassium supplementation being inappropriately administered or withheld according to treatment allocation after a serum potassium measurement); and (3) retaining 28-day follow-up rates ≥90% after surgery. Between August 2017 and April 2018, 723 patients were screened and 160 (22%) were recruited. Potassium protocol violation rate = 9.8%. Follow-up rate at 28 days = 94.3%. Data on planned outcomes for the full trial also were collected.ConclusionsIt is feasible to recruit and randomize patients to a study assessing the impact of maintaining serum potassium concentrations at either ≥3.6 mEq/L or ≥4.5 mEq/L on the incidence of AFACS.Copyright © 2021. Published by Elsevier Inc.
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