跳至主要内容
临床试验/NCT03195647
NCT03195647已完成3 期

PILOT STUDY for the Tight K TRIAL. Arrhythmias on the Cardiac Intensive Care Unit - Does Maintenance of High-normal Serum Potassium Levels Matter?

Barts & The London NHS Trust2 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2017年8月1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
160
试验地点
2
主要终点
Protocol violation rate

研究概览

简要总结

The primary purpose of this pilot study will be feasibility of recruitment. However, in order to further inform a full randomised controlled trial (RCT), information on the incidence of atrial fibrillation (AF) and other arrhythmias, hospital length of stay, resource use and morbidity will be collected.

详细描述

Arrhythmias are common in critical care, with atrial tachyarrhythmias (and especially AF) being the most prevalent. This is especially true after cardiac surgery, with approximately 1 in 3 patients affected. The occurrence of new-onset post-operative AF is associated with increased short and long-term mortality, intensive care unit (ICU) and hospital stay and costs of care. This association appears causal, even after correction for confounding factors.

Potassium (K+) plays an important role in cardiac electrophysiology and abnormal levels may cause arrhythmias. Hypokalaemia, defined as a serum K+ <3.6 milliequivalents per litre (mEq/L) is thus associated with an increased incidence of ventricular arrhythmia after myocardial infarction. Low K+ levels are common following cardiac surgery, and appear marginally lower in those suffering atrial arrhythmias in this context. Despite an absence of proof that this association is causal, efforts to maintain serum [K+] in the 'high-normal' range (4.5 - 5.5 mEq/L) are considered 'routine practice' for AF prevention worldwide. The efficacy of such intervention remains unproven and data supporting this practice is extremely limited, being derived from observational rather than interventional studies. Indeed, no data exist to demonstrate that maintaining a high-normal potassium level is beneficial, or that aggressive replenishment of potassium in patients with heart disease necessarily leads to a better clinical outcome.

Furthermore, the method of potassium supplementation may be problematic. Oral replacement is not possible immediately post-operatively. Central venous administration is thus generally utilised in the early post-operative period. However, this practice is both time-consuming and costly: the intravenous administration of potassium carries recognised clinical risk, and is now prescribed in pre-diluted doses, stored securely for a safety purposes. Oral replacement is commonly associated with profound nausea, and is very poorly tolerated by patients. The investigators have estimated that the annual spending on potassium in cardiothoracic patients at Barts Health National Health Service (NHS) Trust is £100,000, compared to £16,500 for Milrinone (perceived as a high cost drug (2011-2012 prices). Additional costs relating to nursing time, drug checks, and intravenous connection and charting are also accrued. Central venous catheters may also be routinely left in situ solely for the purposes of parenteral potassium replacement; leading to an increased risk of line-related sepsis.

The routine maintenance of serum K+ in the high-normal range is thus a costly and unproven practice.

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

  • All patients undergoing isolated elective coronary artery bypass graft (CABG)

排除标准

  • Age less than 18 years
  • Previous AF
  • Concurrent patient involvement in another clinical study assessing post-operative interventions
  • On-going infection/sepsis at the time of operation
  • Pre-op high-degree atrioventricular (AV) block
  • Pre-op serum K+ greater than 5.5 mEq/L
  • Current or previous use of medication for the purposes of cardiac rhythm management
  • Dialysis dependent end stage renal failure

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 or equals 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

Protocol violation rate

时间窗: 6 months

Feasibility of ensuring that protocol violation rate is no more than 10%

Number of patients successfully randomised into the study to receive standard either usual care or control of potassium at the lower limit of the normal range

时间窗: 6 months

The pilot study will investigate if it is feasible to randomised patients between the control and intervention arms of the study

Total number of patients recruited over a 6 month period

时间窗: 6 months

The pilot study is being conducted to assess if it is feasible to recruit the required patient population into the study. The aim of the pilot is to recruit 160 patients over 6 months from two different centres.

Number of patient with outcome data at 28 days

时间窗: 6 months

This is a feasibility and one of the main outcome will be to assess the number of participants with outcome data at 28 days. The study will aim to follow up 90% of the patients randomised.

次要结局

  • Incidence of new onset atrial fibrillation(Maximum of 5 days)
  • Mean critical care length of stay(Maximum 28 days)
  • Mean hospital length of stay(Maximum 28 days)
  • Incidence of all other arrhythmias, defined using standard diagnostic criteria(Maximum of 5 days)
  • Incidence of in-patient mortality(28 days from randomisation)
  • Incidence of mortality(28 days from randomisation)
  • Cost-effectiveness(28 days from randomisation)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验