Influence of Nebulized Bronchodilatators on SelectedNCT01714401
Nebulized Bronchodilators and Cardiac Repolarization
A study testing Salbutamol 2,5 mg and Salbutamol 5mg in people with Influence of Nebulized Bronchodilatators on Selected and Electrophysiological Parameters, run by Medical University of Gdansk at 2 sites in Poland.
Trial summary
Patients of the ICU's often require bronchodilatory treatment due to bronchospasm caused by conditions like : acute respiratory distress syndrome (ARDS), chronic obstructive pulmonary disease (COPD) or asthma. The β2 adrenergic drugs are one of the most commonly used for this purpose. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Influence of Nebulized Bronchodilatators on Selected, Electrophysiological Parameters
- What is being tested?
- Salbutamol 2,5 mg and Salbutamol 5mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesPoland
- Study dates
- Mar 2012to 31 Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- the necessity of b2 adrenergics an m2 mimetics administration
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Poland2 sites
Medical University of Gdansk - Departament of Anesthesiolog and Intensive cCre
Gdansk, 80-214
Medical University of Gdańsk - Departament of Anesthesiology and Intensive Care
Gdansk, 80-214
About this study
Official title: The Development of Procedures to Optimalize the Intensive Care Units Patients Clinical Condition. Evaluation of Influence of Nebulized Bronchodilatory Drugs on Cardiac Repolarization
Patients of the ICU's often require bronchodilatory treatment due to bronchospasm caused by conditions like : acute respiratory distress syndrome (ARDS), chronic obstructive pulmonary disease (COPD) or asthma. The β2 adrenergic 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 bronchodilatory 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
Read the detailed description
50 mechanically ventilated patients above 18 years of age and with presence of clinical features of bronchospasm requiring treatment with nebulised short-acting beta-2 mimetic.
Participants will be randomly allocated into two equal groups: a group that was to receive the dose of 2.5 mg and a group that was to receive the dose of 5 mg of nebulised salbutamol. The duration of nebulisation will be set for 20 minutes and Holter ECG data are to be recorded for 60 minutes from the initiation of the nebuliser. The acquired Holter ECG data will be analysed at 10 time points: before salbutamol administration and 5, 10, 15, 20, 25, 30, 40, 50, and 60 minutes following initiation of nebulisation. Changes in QT interval, corrected QT intervals calculated using Bazett's correction and the Framingham formula and transmural dispersion of repolarization TDR will be assessed.
- Being tested
- Salbutamol 2,5 mg, Salbutamol 5mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Salbutamol 2,5 mgDrug
Also called Ventolin 2.5mg
20 min nebulization of 2.5 mg of salbutamol
Salbutamol 5mgDrug
Also called Ventolin 5mg
20 min nebulization of 5 mg of salbutamol
| Study group | Role | What they receive |
|---|---|---|
| Salbutamol 2,5 mg | Active comparator | 25 mechanically ventilated patients to receive 2,5mg of nebulised salbtamol (Ventolin) duration of nebulisation - 20 minutes Receives: Drug: Salbutamol 2,5 mg |
| Salbutamol 5mg | Active comparator | 25 mechanically ventilated patients 5 mg of nebulised salbutamol (Ventolin) duration of nebulisation - 20 minutes Receives: Drug: Salbutamol 5mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
QT interval
changes of QT interval after salbutamol nebulisation
Measured: one hour
corrected QT (QTc) interval using Bazett's (QTcB) correction
changes of QTc interval after salbutamol nebulisation
Measured: one hour
corrected QT (QTc) interval using Framingham (QTcF) correction
changes of QTc interval after salbutamol nebulisation
Measured: one hour
Tpeak-Tend
changes in transmural dispersion of repolarization after salbutamol nebulisation
Measured: one hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2012 (estimated)
- Study startMar 2012
- Primary completion30 May 2013
- Study completion31 Dec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Influence of Nebulized Bronchodilatators on SelectedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Gdansk
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Radoslaw Owczuk, Medical University of Gdansk
- Investigators
- Tomasz Jasiński, MD, Principal investigator, Medical University of Gdansk
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01714401
- Sponsor's protocol ID
- TJ-1
- Status last verified
- Dec 2018
- First submitted
- 23 Oct 2012
- Last updated
- 14 Dec 2018
- Results posted
- No
Publications
Jasinski T, Owczuk R, Wujtewicz M. The effect of nebulized salbutamol on atrial electrical properties in mechanically ventilated critically ill patients - a randomized, double-blind study. Anaesthesiol Intensive Ther. 2018;50(4):270-276. doi: 10.5603/AIT.a2018.0031. Epub 2018 Sep 22.
PubMed 30242825
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Development of Procedures to Optimalize the Intensive Care Units Patients Clinical Condition. Evaluation of Influence of Nebulized Bronchodilatory Drugs on Cardiac Repolarization
- ClinicalTrials.gov ID
- NCT01714401
- Acronym / sponsor ID
- TJ-1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Medical University of GdanskUniversity, hospital or other
- Study start
- Mar 2012 (actual)
- Primary completion
- 30 May 2013 (actual)
- Study completion
- 31 Dec 2013 (actual)
- First posted
- 25 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients of the ICU's often require bronchodilatory treatment due to bronchospasm caused by conditions like : acute respiratory distress syndrome (ARDS), chronic obstructive pulmonary disease (COPD) or asthma. The β2 adrenergic 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 bronchodilatory 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
Detailed description
50 mechanically ventilated patients above 18 years of age and with presence of clinical features of bronchospasm requiring treatment with nebulised short-acting beta-2 mimetic.
Participants will be randomly allocated into two equal groups: a group that was to receive the dose of 2.5 mg and a group that was to receive the dose of 5 mg of nebulised salbutamol. The duration of nebulisation will be set for 20 minutes and Holter ECG data are to be recorded for 60 minutes from the initiation of the nebuliser. The acquired Holter ECG data will be analysed at 10 time points: before salbutamol administration and 5, 10, 15, 20, 25, 30, 40, 50, and 60 minutes following initiation of nebulisation. Changes in QT interval, corrected QT intervals calculated using Bazett's correction and the Framingham formula and transmural dispersion of repolarization TDR will be assessed.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Salbutamol 2,5 mg | Active comparator | Drug: Salbutamol 2,5 mg25 mechanically ventilated patients to receive 2,5mg of nebulised salbtamol (Ventolin) duration of nebulisation - 20 minutes |
| Salbutamol 5mg | Active comparator | Drug: Salbutamol 5mg25 mechanically ventilated patients 5 mg of nebulised salbutamol (Ventolin) duration of nebulisation - 20 minutes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- the necessity of b2 adrenergics an m2 mimetics administration
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Salbutamol 2,5 mgAlso: Ventolin 2.5mg20 min nebulization of 2.5 mg of salbutamol | Drug | Salbutamol 2,5 mg |
| Salbutamol 5mgAlso: Ventolin 5mg20 min nebulization of 5 mg of salbutamol | Drug | Salbutamol 5mg |
Primary outcome
QT interval
Time frame: one hour
changes of QT interval after salbutamol nebulisation
corrected QT (QTc) interval using Bazett's (QTcB) correction
Time frame: one hour
changes of QTc interval after salbutamol nebulisation
corrected QT (QTc) interval using Framingham (QTcF) correction
Time frame: one hour
changes of QTc interval after salbutamol nebulisation
Tpeak-Tend
Time frame: one hour
changes in transmural dispersion of repolarization after salbutamol nebulisation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2018.
- Derived from this study: PubMed 30242825Jasinski T, Owczuk R, Wujtewicz M. The effect of nebulized salbutamol on atrial electrical properties in mechanically ventilated critically ill patients - a randomized, double-blind study. Anaesthesiol Intensive Ther. 2018;50(4):270-276. doi: 10.5603/AIT.a2018.0031. Epub 2018 Sep 22.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tomasz Jasiński, MD principal investigator
Medical University of Gdansk
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Salbutamol 2,5 mg and Salbutamol 5mg in people with Influence of Nebulized Bronchodilatators on Selected and Electrophysiological Parameters, run by Medical University of Gdansk at 2 sites in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
QT interval (time frame: one hour). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01714401, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2018; AzTrials last refreshed its copy on 30 Oct 2026.