Nebulized Bronchodilatators and Cardiac Repolarization
The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2012 by Medical University of Gdansk.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Medical University of Gdansk
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
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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:
Drug Information available for:
Albuterol
Ipratropium bromide
Levalbuterol
Levalbuterol hydrochloride
Albuterol sulfate
Levalbuterol tartrate
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 (Adult, Senior) |
| 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
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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
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 |
| Health Authority: | Poland: The Central Register of Clinical Trials |
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 September 27, 2016