维持孤立性冠状动脉旁路移植术后 120 小时血清钾浓度≥3.6mEq/L 与≥4.5mEq/L 对新发心房颤动发生率的影响：一项随机非劣效性试验方案。
Impact of maintaining serum potassium concentration ≥ 3.6mEq/L versus ≥ 4.5mEq/L for 120 hours after isolated coronary artery bypass graft surgery on incidence of new onset atrial fibrillation: Protocol for a randomized non-inferiority trial.
机构信息
Faculty of Biology, Division of Cardiovascular Sciences, School of Medical Sciences, Medicine and Health, University of Manchester, Manchester Academic Health Science Centre, Manchester, United Kingdom.
Manchester Heart Institute, Manchester University Foundation NHS Trust, Manchester, United Kingdom.
出版信息
PLoS One. 2024 Mar 13;19(3):e0296525. doi: 10.1371/journal.pone.0296525. eCollection 2024.
BACKGROUND
Atrial Fibrillation After Cardiac Surgery (AFACS) occurs in about one in three patients following Coronary Artery Bypass Grafting (CABG). It is associated with increased short- and long-term morbidity, mortality and costs. To reduce AFACS incidence, efforts are often made to maintain serum potassium in the high-normal range (≥ 4.5mEq/L). However, there is no evidence that this strategy is efficacious. Furthermore, the approach is costly, often unpleasant for patients, and risks causing harm. We describe the protocol of a planned randomized non-inferiority trial to investigate the impact of intervening to maintain serum potassium ≥ 3.6 mEq/L vs ≥ 4.5 mEq/L on incidence of new-onset AFACS after isolated elective CABG.
METHODS
Patients undergoing isolated CABG at sites in the UK and Germany will be recruited, randomized 1:1 and stratified by site to protocols maintaining serum potassium at either ≥ 3.6 mEq/L or ≥ 4.5 mEq/L. Participants will not be blind to treatment allocation. The primary endpoint is AFACS, defined as an episode of atrial fibrillation, flutter or tachycardia lasting ≥ 30 seconds until hour 120 after surgery, which is both clinically detected and electrocardiographically confirmed. Assuming a 35% incidence of AFACS in the 'tight control group', and allowing for a 10% loss to follow-up, 1684 participants are required to provide 90% certainty that the upper limit of a one-sided 97.5% confidence interval (CI) will exclude a > 10% difference in favour of tight potassium control. Secondary endpoints include mortality, use of hospital resources and incidence of dysrhythmias not meeting the primary endpoint (detected using continuous heart rhythm monitoring).
DISCUSSION
The Tight K Trial will assess whether a protocol to maintain serum potassium ≥ 3.6 mEq/L is non inferior to maintaining serum potassium ≥ 4.5 mEq/L in preventing new-onset AFACS after isolated CABG.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT04053816. Registered on 13 August 2019. Last update 7 January 2021.
背景
心脏手术后心房颤动（AFACS）在冠状动脉旁路移植术（CABG）后约三分之一的患者中发生。它与短期和长期发病率、死亡率和成本增加有关。为了降低 AFACS 的发生率，人们通常努力将血清钾维持在高正常范围内（≥4.5mEq/L）。然而，没有证据表明这种策略是有效的。此外，这种方法成本高昂，常常令患者不适，并有可能造成伤害。我们描述了一项计划中的随机非劣效性试验方案，以研究干预以维持血清钾≥3.6mEq/L 与≥4.5mEq/L 对孤立择期 CABG 后新发 AFACS 发生率的影响。
方法
将在英国和德国的地点接受孤立 CABG 的患者招募、随机分为 1:1 组，并按地点分层，以维持血清钾分别在≥3.6mEq/L 或≥4.5mEq/L。参与者不会对治疗分配进行盲法。主要终点是 AFACS，定义为手术后 30 秒至 120 小时持续≥30 秒的心房颤动、扑动或心动过速发作，这既是临床检测到的，也是心电图证实的。假设“严格控制组”的 AFACS 发生率为 35%，并允许 10%的失访，需要 1684 名参与者提供 90%的把握度，以确保单侧 97.5%置信区间（CI）上限排除有利于严格钾控制的差异>10%。次要终点包括死亡率、医院资源的使用和不符合主要终点的心律失常发生率（使用连续心率监测检测）。
讨论
Tight K 试验将评估维持血清钾≥3.6mEq/L 的方案是否不劣于维持血清钾≥4.5mEq/L，以防止孤立 CABG 后新发 AFACS。
试验注册
ClinicalTrials.gov 标识符：NCT04053816。于 2019 年 8 月 13 日注册。最后更新日期为 2021 年 1 月 7 日。
Zotero 插件