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Nebulized Bronchodilatators and Cardiac Repolarization

This study is currently recruiting participants.
Verified October 2012 by Medical University of Gdansk
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 (Subject, Caregiver, 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:

U.S. FDA Resources

Further study details as provided by Medical University of Gdansk:

Primary Outcome Measures:
  • Changes of electrophysiological parameters after nebulized bronchodilatator [ Time Frame: one hour ] [ Designated as safety issue: No ]

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
Genders Eligible for Study:   Both
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
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

No publications provided

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
Health Authority: Poland: The Central Register of Clinical Trials

Additional relevant MeSH terms:
Albuterol
Ipratropium
Tocolytic Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
 Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Cholinergic Antagonists
Cholinergic Agents

ClinicalTrials.gov processed this record on May 19, 2013