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Nebulized Bronchodilators and Cardiac Repolarization

Sponsor
Medical University of Gdansk (Other)
Overall Status
Completed
CT.gov ID
NCT01714401
Collaborator
(none)
50
Enrollment
2
Locations
2
Arms
22
Actual Duration (Months)
25
Patients Per Site
1.1
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Salbutamol 2,5 mg
  • Drug: Salbutamol 5mg
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Other
Official Title:
The Development of Procedures to Optimalize the Intensive Care Units Patients Clinical Condition. Evaluation of Influence of Nebulized Bronchodilatory Drugs on Cardiac Repolarization
Actual Study Start Date :
Mar 1, 2012
Actual Primary Completion Date :
May 30, 2013
Actual Study Completion Date :
Dec 31, 2013

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Salbutamol 2,5 mg

25 mechanically ventilated patients to receive 2,5mg of nebulised salbtamol (Ventolin) duration of nebulisation - 20 minutes

Drug: Salbutamol 2,5 mg
20 min nebulization of 2.5 mg of salbutamol
Other Names:
  • Ventolin 2.5mg

    		•
    Active Comparator: Salbutamol 5mg

    25 mechanically ventilated patients 5 mg of nebulised salbutamol (Ventolin) duration of nebulisation - 20 minutes

    Drug: Salbutamol 5mg
    20 min nebulization of 5 mg of salbutamol
    Other Names:
  • Ventolin 5mg

    		•

    Outcome Measures

    Primary Outcome Measures

    1. QT interval [one hour]

      changes of QT interval after salbutamol nebulisation

    2. corrected QT (QTc) interval using Bazett's (QTcB) correction [one hour]

      changes of QTc interval after salbutamol nebulisation

    3. corrected QT (QTc) interval using Framingham (QTcF) correction [one hour]

      changes of QTc interval after salbutamol nebulisation

    4. Tpeak-Tend [one hour]

      changes in transmural dispersion of repolarization after salbutamol nebulisation

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Medical University of Gdansk - Departament of Anesthesiolog and Intensive cCre Gdansk Poland 80-214
    2 Medical University of Gdańsk - Departament of Anesthesiology and Intensive Care Gdańsk Poland 80-214

    Sponsors and Collaborators

    • Medical University of Gdansk

    Investigators

    • Principal Investigator: Tomasz Jasiński, MD, Medical University of Gdansk

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Radoslaw Owczuk, associate professor, Medical University of Gdansk
    ClinicalTrials.gov Identifier:
    NCT01714401
    Other Study ID Numbers:
    • TJ-1
    First Posted:
    Oct 25, 2012
    Last Update Posted:
    Dec 14, 2018
    Last Verified:
    Dec 1, 2018
    Additional relevant MeSH terms:
    Albuterol

    Study Results

    No Results Posted as of Dec 14, 2018