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临床试验/NCT04053816
NCT04053816已完成3 期

The TIGHT-K STUDY. Prevention of Dysrhythmias on the Cardiac Intensive Care Unit - Does Maintenance of High-normal Serum Potassium Levels Matter

Barts & The London NHS Trust1 个研究点 分布在 1 个国家目标入组 1,684 人开始时间: 2020年10月20日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
1,684
试验地点
1
主要终点
The presence of new onset AFACS until until hour 120 after initial admission to ICU/post-operative care facility, or discharge from hospital, whichever occurs first.

研究概览

简要总结

The purpose of this study is to determine whether a strategy of maintaining serum potassium levels at ≥3.6 mEq/L is non-inferior to a strategy of usual treatment (≥4.5 mEq/L) on the occurrence of new onset atrial fibrillation after cardiac surgery (AFACS) in patients undergoing isolated coronary artery bypass graft (CABG) surgery.

详细描述

At least one in three patients is affected by atrial fibrillation after cardiac surgery(AFACS), with most episodes occurring in the first five postoperative days. AF occurrence is associated with increased morbidity, short and long-term mortality, intensive care unit (ICU) and hospital stay and cost of care. Persistence of these associations after adjustment for potential confounding factors suggests that they may be causal. The incidence and prevalence of AF and its associated costs are expected to increase as the surgical population ages. Extensive effort is undertaken to prevent AF after cardiac surgery from occurring, but clinical practice in this area is highly variable and the evidence base for most interventions is sparse.

Potassium plays an important role in cardiac electrophysiology. Serum potassium concentrations ([K+]) are commonly low following cardiac surgery, and appear marginally lower in those suffering atrial arrhythmias in non-surgical cohorts. Despite an absence of proof that this association is causal, efforts to maintain serum [K+] in the 'high-normal' range (≥ 4.5 mEq/L), as opposed to just intervening if potassium drops below its lower 'normal' threshold (<3.6 mEq/L), are considered 'routine practice' for AF prevention in post-surgical patients in many centres across the world.

From the (unpublished) data from our Tight-K Feasibility Study, all 160 patients would have required at least one dose of potassium to supplement their levels to this high-normal range and 45.5% of all serum [K+] measurements were below 4.5mEq/L at some point. Data from the same pilot study show a median number of potassium doses given in the 'tight' group (high-normal serum potassium target) of seven, compared to a median of one, with most patients not receiving any potassium supplementation at all, in the 'relaxed' group. This demonstrated for the first time ever, that the practice does achieve a separation in serum potassium levels between the two groups, so the protocol is indeed effective in achieving higher serum potassium levels.

The efficacy of the practice of maintaining high-normal serum potassium levels for the prevention of AF after cardiac surgery, however, remains unproven and data supporting it are extremely limited, being derived from observational studies rather than randomised trials. Indeed, no data exist to demonstrate that maintaining a high-normal potassium level is beneficial in these circumstances, or that aggressive replenishment of potassium in these patients improves outcome.

Meanwhile, potassium supplementation may cause discomfort or harm. Routine central venous potassium administration in the early post-operative period, when oral supplementation is not possible, is time-consuming, costly and associated with clinical risk: rapid infusion can prove fatal, and leaving central venous catheters in situ for the sole purpose of potassium replacement increases infection risk. Oral replacement (when feasible) is commonly associated with profound nausea and gastrointestinal side effects, and is very poorly tolerated by patients. The annual costs of intravenous potassium exceed those for other drugs in many cardiac surgical units due to the large quantities administered. Nursing time (e.g. for drug checks and administration) will add to this cost.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Scheduled to have isolated CABG surgery
  • Patient in sinus rhythm

排除标准

  • Age less than 18 years
  • Previous history of Atrial Fibrillation, Atrial Flutter and/or Atrial Tachyarrhythmia
  • Pre-operative high-degree atrioventricular (AV) block (defined as Mobitz type 2 second degree AV block or complete heart block)
  • Pre-operative serum [K+] greater than 5.5 mEq/L
  • Current/previous use of medication for the purposes of cardiac rhythm management
  • Dialysis-dependent end-stage renal failure
  • Concurrent patient involvement in another clinical trial assessing cardiac rhythm post-operative interventions
  • Unable to give informed consent

研究组 & 干预措施

Relaxed control

Experimental

Those randomised to the 'Relaxed' Group will receive potassium supplementation only if their serum potassium drops below 3.6 mEq/L.

干预措施: Potassium (Drug)

Tight control

Active Comparator

Patients randomised to the 'Tight' group will receive potassium supplementation if their serum potassium falls below 4.5 mEq/L (current practice).

干预措施: Potassium (Drug)

结局指标

主要结局

The presence of new onset AFACS until until hour 120 after initial admission to ICU/post-operative care facility, or discharge from hospital, whichever occurs first.

时间窗: Maximum of 5 days

Episode of AFACS lasting ≥30 seconds that is both clinically detected and electrocardiographically confirmed (on either a 12-lead electrocardiogram (ECG), telemetry or Holter monitoring

次要结局

  • 6-month mortality(Maximum 6 months)
  • The incidence of new onset AFACS(Maximum of 5 days)
  • The incidence of at least one episode of AFACS(Maximum of 5 days)
  • Number of patients experiencing at least one episode of a non-AF arrhythmia.(Maximum of 5 days)
  • In-patient mortality(Maximum 6 months)
  • Critical care length of stay(Maximum 6 months)
  • Hospital length of stay(Maximum 6 months)
  • Costs relating to potassium therapy(Maximum of 5 days)
  • Quality of life at 6 months: questionnaire(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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