The Development of Procedures to Optimalize the Intensive Care Units Patients Clinical Condition. Evaluation of Influence of Nebulized Bronchodilatory Drugs on Cardiac Repolarization
Overview
- Phase
- Not Applicable
- Intervention
- Salbutamol 2,5 mg
- Conditions
- Influence of Nebulized Bronchodilatators on Selected
- Sponsor
- Medical University of Gdansk
- Enrollment
- 50
- Locations
- 2
- Primary Endpoint
- corrected QT (QTc) interval using Bazett's (QTcB) correction
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
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
Detailed Description
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.
Investigators
Radoslaw Owczuk
associate professor
Medical University of Gdansk
Eligibility Criteria
Inclusion Criteria
- •the necessity of b2 adrenergics an m2 mimetics administration
Exclusion Criteria
- •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
Arms & Interventions
Salbutamol 2,5 mg
25 mechanically ventilated patients to receive 2,5mg of nebulised salbtamol (Ventolin) duration of nebulisation - 20 minutes
Intervention: Salbutamol 2,5 mg
Salbutamol 5mg
25 mechanically ventilated patients 5 mg of nebulised salbutamol (Ventolin) duration of nebulisation - 20 minutes
Intervention: Salbutamol 5mg
Outcomes
Primary Outcomes
corrected QT (QTc) interval using Bazett's (QTcB) correction
Time Frame: one hour
changes of QTc interval after salbutamol nebulisation
Tpeak-Tend
Time Frame: one hour
changes in transmural dispersion of repolarization after salbutamol nebulisation
QT interval
Time Frame: one hour
changes of QT interval after salbutamol nebulisation
corrected QT (QTc) interval using Framingham (QTcF) correction
Time Frame: one hour
changes of QTc interval after salbutamol nebulisation