Nebulized Bronchodilators and Cardiac Repolarization

December 12, 2018 updated by: Radoslaw Owczuk, Medical University of Gdansk

The Development of Procedures to Optimalize the Intensive Care Units Patients Clinical Condition. Evaluation of Influence of Nebulized Bronchodilatory Drugs on Cardiac Repolarization

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Gdansk, Poland, 80-214
        • Medical University of Gdansk - Departament of Anesthesiolog and Intensive cCre
      • Gdańsk, Poland, 80-214
        • Medical University of Gdansk - Departament of Anesthesiology and Intensive Care

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
QT interval
Time Frame: one hour
changes of QT interval after salbutamol nebulisation
one hour
corrected QT (QTc) interval using Bazett's (QTcB) correction
Time Frame: one hour
changes of QTc interval after salbutamol nebulisation
one hour
corrected QT (QTc) interval using Framingham (QTcF) correction
Time Frame: one hour
changes of QTc interval after salbutamol nebulisation
one hour
Tpeak-Tend
Time Frame: one hour
changes in transmural dispersion of repolarization after salbutamol nebulisation
one hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Gdansk

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2012

Primary Completion (Actual)

May 30, 2013

Study Completion (Actual)

December 31, 2013

Study Registration Dates

First Submitted

October 23, 2012

First Submitted That Met QC Criteria

October 24, 2012

First Posted (Estimate)

October 25, 2012

Study Record Updates

Last Update Posted (Actual)

December 14, 2018

Last Update Submitted That Met QC Criteria

December 12, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TJ-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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