Nebulized Bronchodilatators and Cardiac Repolarization

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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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, Senior)
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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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