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Nebulized Bronchodilatators and Cardiac Repolarization

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ClinicalTrials.gov Identifier: NCT01714401
Recruitment Status : Unknown
Verified October 2012 by Radoslaw Owczuk, Medical University of Gdansk.
Recruitment status was:  Recruiting
First Posted : October 25, 2012
Last Update Posted : October 25, 2012
Sponsor:
Information provided by (Responsible Party):
Radoslaw Owczuk, Medical University of Gdansk

Study Description
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Brief Summary:
Patients of the ICU's often require bronchodialtatory treatment due to bronchospazm caused by conditions like : ARDS, COPD or asthma. The β2 adreneregic 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 bronchodilatatory 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: ventolin 2.5mg Drug: Ventolin 5mg Drug: Atrovent 0.5mg Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Official Title: The Development of Procedures to Optimalize the Intensive Care Units Patients Clinical Condition. Evaluation of Influence of Nebulized Bronchodilatatory Drugs on Cardiac Repolarization
Study Start Date : March 2012
Estimated Primary Completion Date : April 2013

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Salbutamol 2,5 mg Drug: ventolin 2.5mg
20 min nebulization of 2.5 mg of salbutamol
Active Comparator: Salbutamol 5mg Drug: Ventolin 5mg
20 min nebulization of 5 mg of salbutamol
Active Comparator: Ipratropium 0.5 Drug: Atrovent 0.5mg
20 min nebulization of 0.5 mg of ipratropium bromide


Outcome Measures
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Primary Outcome Measures :
  1. Changes of electrophysiological parameters after nebulized bronchodilatator [ Time Frame: one hour ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT01714401


Contacts
Contact: Tomasz Jasinski, MD 0048-058-349-32-82 tjasinski@uck.gda.pl

Locations
Poland
Medical University of Gdansk - Departament of Anesthesiolog and Intensive cCre Recruiting
Gdansk, Poland, 80-214
Contact: Tomasz Jasinski, MD       tjasinski@uck.gda.pl   
Principal Investigator: Radoslaw Owczuk, Ph.D.         
Sub-Investigator: Tomasz Jasinski, MD         
Medical University of Gdańsk - Departament of Anesthesiology and Intensive Care Recruiting
Gdańsk, Poland, 80-214
Principal Investigator: Radoslaw Owczuk, Ph.D.         
Sub-Investigator: Tomasz Jasinski, MD         
Sponsors and Collaborators
Medical University of Gdansk
More Information
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Responsible Party: Radoslaw Owczuk, associate professor, Medical University of Gdansk
ClinicalTrials.gov Identifier: NCT01714401     History of Changes
Other Study ID Numbers: TJ-1
First Posted: October 25, 2012    Key Record Dates
Last Update Posted: October 25, 2012
Last Verified: October 2012

Additional relevant MeSH terms:
Albuterol
Ipratropium
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
Cholinergic Antagonists
Cholinergic Agents