<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01714401</url>
  </required_header>
  <id_info>
    <org_study_id>TJ-1</org_study_id>
    <nct_id>NCT01714401</nct_id>
  </id_info>
  <brief_title>Nebulized Bronchodilators and Cardiac Repolarization</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Gdansk</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University of Gdansk</source>
  <brief_summary>
    <textblock>
      Patients of the ICU's often require bronchodilatory treatment due to bronchospasm caused by&#xD;
      conditions like : acute respiratory distress syndrome (ARDS), chronic obstructive pulmonary&#xD;
      disease (COPD) or asthma. The β2 adrenergic drugs are one of the most commonly used for this&#xD;
      purpose. However it is known that they may cause tachycardia and may have substantial&#xD;
      proarrhythmic effect. The investigators' aim is to estimate the influence of nebulized&#xD;
      bronchodilatory drugs on selected electrophysiological parameters, whose changes are&#xD;
      generally recognized as potentially increasing the risk of ventricular and supraventricular&#xD;
      arrhythmias. Two drugs will be compared - salbutamol given in two doses and ipratropium&#xD;
      bromide&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      50 mechanically ventilated patients above 18 years of age and with presence of clinical&#xD;
      features of bronchospasm requiring treatment with nebulised short-acting beta-2 mimetic.&#xD;
&#xD;
      Participants will be randomly allocated into two equal groups: a group that was to receive&#xD;
      the dose of 2.5 mg and a group that was to receive the dose of 5 mg of nebulised salbutamol.&#xD;
      The duration of nebulisation will be set for 20 minutes and Holter ECG data are to be&#xD;
      recorded for 60 minutes from the initiation of the nebuliser. The acquired Holter ECG data&#xD;
      will be analysed at 10 time points: before salbutamol administration and 5, 10, 15, 20, 25,&#xD;
      30, 40, 50, and 60 minutes following initiation of nebulisation. Changes in QT interval,&#xD;
      corrected QT intervals calculated using Bazett's correction and the Framingham formula and&#xD;
      transmural dispersion of repolarization TDR will be assessed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 2012</start_date>
  <completion_date type="Actual">December 31, 2013</completion_date>
  <primary_completion_date type="Actual">May 30, 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>QT interval</measure>
    <time_frame>one hour</time_frame>
    <description>changes of QT interval after salbutamol nebulisation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>corrected QT (QTc) interval using Bazett's (QTcB) correction</measure>
    <time_frame>one hour</time_frame>
    <description>changes of QTc interval after salbutamol nebulisation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>corrected QT (QTc) interval using Framingham (QTcF) correction</measure>
    <time_frame>one hour</time_frame>
    <description>changes of QTc interval after salbutamol nebulisation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Tpeak-Tend</measure>
    <time_frame>one hour</time_frame>
    <description>changes in transmural dispersion of repolarization after salbutamol nebulisation</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Influence of Nebulized Bronchodilatators on Selected</condition>
  <condition>Electrophysiological Parameters</condition>
  <arm_group>
    <arm_group_label>Salbutamol 2,5 mg</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>25 mechanically ventilated patients to receive 2,5mg of nebulised salbtamol (Ventolin) duration of nebulisation - 20 minutes</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Salbutamol 5mg</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>25 mechanically ventilated patients 5 mg of nebulised salbutamol (Ventolin) duration of nebulisation - 20 minutes</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Salbutamol 2,5 mg</intervention_name>
    <description>20 min nebulization of 2.5 mg of salbutamol</description>
    <arm_group_label>Salbutamol 2,5 mg</arm_group_label>
    <other_name>Ventolin 2.5mg</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Salbutamol 5mg</intervention_name>
    <description>20 min nebulization of 5 mg of salbutamol</description>
    <arm_group_label>Salbutamol 5mg</arm_group_label>
    <other_name>Ventolin 5mg</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  the necessity of b2 adrenergics an m2 mimetics administration&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients with past medical history of ventricular arrhythmias ( ventricular&#xD;
             tachycardia, ventricular fibril, Torsade de pointes)&#xD;
&#xD;
          -  patients with persistent atrial fibrillation&#xD;
&#xD;
          -  patients with abnormal plasma sodium, potassium, magnesium, and ionized calcium&#xD;
             concentration&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tomasz Jasiński, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical University of Gdansk</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Medical University of Gdansk - Departament of Anesthesiolog and Intensive cCre</name>
      <address>
        <city>Gdansk</city>
        <zip>80-214</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical University of Gdańsk - Departament of Anesthesiology and Intensive Care</name>
      <address>
        <city>Gdańsk</city>
        <zip>80-214</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Poland</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>October 23, 2012</study_first_submitted>
  <study_first_submitted_qc>October 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 25, 2012</study_first_posted>
  <last_update_submitted>December 12, 2018</last_update_submitted>
  <last_update_submitted_qc>December 12, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 14, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical University of Gdansk</investigator_affiliation>
    <investigator_full_name>Radoslaw Owczuk</investigator_full_name>
    <investigator_title>associate professor</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Albuterol</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01714401
org study id: TJ-1
nct id: NCT01714401
lead sponsor: 
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
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Triple (Participant, Care Provider, Investigator)
measure: QT interval
time frame: one hour
description: changes of QT interval after salbutamol nebulisation
measure: corrected QT (QTc) interval using Bazett's (QTcB) correction
time frame: one hour
description: changes of QTc interval after salbutamol nebulisation
measure: corrected QT (QTc) interval using Framingham (QTcF) correction
time frame: one hour
description: changes of QTc interval after salbutamol nebulisation
measure: Tpeak-Tend
time frame: one hour
description: changes in transmural dispersion of repolarization after salbutamol nebulisation
arm group label: Salbutamol 2,5 mg
arm group type: Active Comparator
description: 25 mechanically ventilated patients to receive 2,5mg of nebulised salbtamol (Ventolin) duration of nebulisation - 20 minutes
arm group label: Salbutamol 5mg
arm group type: Active Comparator
description: 25 mechanically ventilated patients 5 mg of nebulised salbutamol (Ventolin) duration of nebulisation - 20 minutes
intervention type: Drug
intervention name: Salbutamol 2,5 mg
description: 20 min nebulization of 2.5 mg of salbutamol
arm group label: Salbutamol 2,5 mg
other name: Ventolin 2.5mg
intervention type: Drug
intervention name: Salbutamol 5mg
description: 20 min nebulization of 5 mg of salbutamol
arm group label: Salbutamol 5mg
other name: Ventolin 5mg
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Tomasz Jasiński, MD
role: Principal Investigator
affiliation: Medical University of Gdansk
facility: 
facility: 
country: Poland
responsible party type: Principal Investigator
investigator affiliation: Medical University of Gdansk
investigator full name: Radoslaw Owczuk
investigator title: associate professor
mesh term: Albuterol