The Development of Procedures to Optimalize the Intensive Care Units Patients Clinical Condition. Evaluation of Influence of Nebulized Bronchodilatory Drugs on Cardiac Repolarization
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- corrected QT (QTc) interval using Bazett's (QTcB) correction
研究概览
简要总结
Patients of the ICU's often require bronchodilatory treatment due to bronchospasm caused by conditions like : acute respiratory distress syndrome (ARDS), chronic obstructive pulmonary disease (COPD) or asthma. The β2 adrenergic drugs are one of the most commonly used for this purpose. However it is known that they may cause tachycardia and may have substantial proarrhythmic effect. The investigators' aim is to estimate the influence of nebulized bronchodilatory drugs on selected electrophysiological parameters, whose changes are generally recognized as potentially increasing the risk of ventricular and supraventricular arrhythmias. Two drugs will be compared - salbutamol given in two doses and ipratropium bromide
详细描述
50 mechanically ventilated patients above 18 years of age and with presence of clinical features of bronchospasm requiring treatment with nebulised short-acting beta-2 mimetic.
Participants will be randomly allocated into two equal groups: a group that was to receive the dose of 2.5 mg and a group that was to receive the dose of 5 mg of nebulised salbutamol. The duration of nebulisation will be set for 20 minutes and Holter ECG data are to be recorded for 60 minutes from the initiation of the nebuliser. The acquired Holter ECG data will be analysed at 10 time points: before salbutamol administration and 5, 10, 15, 20, 25, 30, 40, 50, and 60 minutes following initiation of nebulisation. Changes in QT interval, corrected QT intervals calculated using Bazett's correction and the Framingham formula and transmural dispersion of repolarization TDR will be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •the necessity of b2 adrenergics an m2 mimetics administration
排除标准
- •patients with past medical history of ventricular arrhythmias ( ventricular tachycardia, ventricular fibril, Torsade de pointes)
- •patients with persistent atrial fibrillation
- •patients with abnormal plasma sodium, potassium, magnesium, and ionized calcium concentration
研究组 & 干预措施
Salbutamol 2,5 mg
25 mechanically ventilated patients to receive 2,5mg of nebulised salbtamol (Ventolin) duration of nebulisation - 20 minutes
干预措施: Salbutamol 2,5 mg (Drug)
Salbutamol 5mg
25 mechanically ventilated patients 5 mg of nebulised salbutamol (Ventolin) duration of nebulisation - 20 minutes
干预措施: Salbutamol 5mg (Drug)
结局指标
主要结局
corrected QT (QTc) interval using Bazett's (QTcB) correction
时间窗: one hour
changes of QTc interval after salbutamol nebulisation
Tpeak-Tend
时间窗: one hour
changes in transmural dispersion of repolarization after salbutamol nebulisation
QT interval
时间窗: one hour
changes of QT interval after salbutamol nebulisation
corrected QT (QTc) interval using Framingham (QTcF) correction
时间窗: one hour
changes of QTc interval after salbutamol nebulisation
次要结局
未报告次要终点
研究者
Radoslaw Owczuk
associate professor
Medical University of Gdansk