Nebulized Bronchodilatators and Cardiac Repolarization

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified October 2012 by Radoslaw Owczuk, Medical University of Gdansk.
Recruitment status was: Recruiting

Sponsor:

Information provided by (Responsible Party):

Radoslaw Owczuk, Medical University of Gdansk

ClinicalTrials.gov Identifier:

NCT01714401

First received: October 23, 2012

Last updated: October 24, 2012

Last verified: October 2012

History of Changes

Purpose

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	Intervention
Influence of Nebulized Bronchodilatators on Selected Electrophysiological Parameters	Drug: ventolin 2.5mg Drug: Ventolin 5mg Drug: Atrovent 0.5mg


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (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

Resource links provided by NLM:

Drug Information available for: Albuterol Levalbuterol Levalbuterol hydrochloride Albuterol sulfate Levalbuterol tartrate

U.S. FDA Resources

Further study details as provided by Radoslaw Owczuk, Medical University of Gdansk:

Primary Outcome Measures:

Changes of electrophysiological parameters after nebulized bronchodilatator [ Time Frame: one hour ]


Estimated Enrollment:	75
Study Start Date:	March 2012
Estimated Primary Completion Date:	April 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility


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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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


Responsible Party:	Radoslaw Owczuk, associate professor, Medical University of Gdansk
ClinicalTrials.gov Identifier:	NCT01714401 History of Changes
Other Study ID Numbers:	TJ-1
Study First Received:	October 23, 2012
Last Updated:	October 24, 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

ClinicalTrials.gov processed this record on June 26, 2017

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