医学
随机化
心房颤动
随机对照试验
钾
心脏外科
入射(几何)
麻醉
旁路移植
临床试验
冠状动脉搭桥手术
动脉
内科学
急诊医学
心脏病学
外科
有机化学
化学
物理
光学
作者
Niall Campbell,Elizabeth Allen,Hugh Montgomery,J Aron,Ruth R Canter,Matthew Dodd,Julie Sanders,Joanna Sturgess,Diana Elbourne,Ben O’Brien
标识
DOI:10.1053/j.jvca.2021.06.021
摘要
Serum 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.Pilot and feasibility study of full trial protocol.Two university tertiary-care hospitals.A total of 160 individuals undergoing first-time elective isolated coronary artery bypass grafting.Randomization (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.Primary 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.It 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.
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