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Nebulized Bronchodilators and Cardiac Repolarization

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01714401
Recruitment Status : Completed
First Posted : October 25, 2012
Last Update Posted : December 14, 2018
Information provided by (Responsible Party):
Radoslaw Owczuk, Medical University of Gdansk

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
Influence of Nebulized Bronchodilatators on Selected Electrophysiological Parameters Drug: Salbutamol 2,5 mg Drug: Salbutamol 5mg Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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 : March 2012
Actual Primary Completion Date : May 30, 2013
Actual Study Completion Date : December 31, 2013

Resource links provided by the National Library of Medicine

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 Name: 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 Name: Ventolin 5mg

Primary Outcome Measures :
  1. QT interval [ Time Frame: one hour ]
    changes of QT interval after salbutamol nebulisation

  2. corrected QT (QTc) interval using Bazett's (QTcB) correction [ Time Frame: one hour ]
    changes of QTc interval after salbutamol nebulisation

  3. corrected QT (QTc) interval using Framingham (QTcF) correction [ Time Frame: one hour ]
    changes of QTc interval after salbutamol nebulisation

  4. Tpeak-Tend [ Time Frame: one hour ]
    changes in transmural dispersion of repolarization after salbutamol nebulisation

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01714401

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Medical University of Gdansk - Departament of Anesthesiolog and Intensive cCre
Gdansk, Poland, 80-214
Medical University of Gdańsk - Departament of Anesthesiology and Intensive Care
Gdańsk, Poland, 80-214
Sponsors and Collaborators
Medical University of Gdansk
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Principal Investigator: Tomasz Jasiński, MD Medical University of Gdansk

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Responsible Party: Radoslaw Owczuk, associate professor, Medical University of Gdansk Identifier: NCT01714401     History of Changes
Other Study ID Numbers: TJ-1
First Posted: October 25, 2012    Key Record Dates
Last Update Posted: December 14, 2018
Last Verified: December 2018

Additional relevant MeSH terms:
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Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action