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Nebulized Bronchodilators and Cardiac Repolarization

NCT ID: NCT01714401

Last Updated: 2018-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2013-12-31

Brief Summary

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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

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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.

Conditions

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Influence of Nebulized Bronchodilatators on Selected Electrophysiological Parameters

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Salbutamol 2,5 mg

25 mechanically ventilated patients to receive 2,5mg of nebulised salbtamol (Ventolin) duration of nebulisation - 20 minutes

Group Type ACTIVE_COMPARATOR

Salbutamol 2,5 mg

Intervention Type DRUG

20 min nebulization of 2.5 mg of salbutamol

Salbutamol 5mg

25 mechanically ventilated patients 5 mg of nebulised salbutamol (Ventolin) duration of nebulisation - 20 minutes

Group Type ACTIVE_COMPARATOR

Salbutamol 5mg

Intervention Type DRUG

20 min nebulization of 5 mg of salbutamol

Interventions

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Salbutamol 2,5 mg

20 min nebulization of 2.5 mg of salbutamol

Intervention Type DRUG

Salbutamol 5mg

20 min nebulization of 5 mg of salbutamol

Intervention Type DRUG

Other Intervention Names

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Ventolin 2.5mg Ventolin 5mg

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Gdansk

OTHER

Sponsor Role lead

Responsible Party

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Radoslaw Owczuk

associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tomasz Jasiński, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Gdansk

Locations

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Medical University of Gdansk - Departament of Anesthesiolog and Intensive cCre

Gdansk, , Poland

Site Status

Medical University of Gdańsk - Departament of Anesthesiology and Intensive Care

Gdansk, , Poland

Site Status

Countries

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Poland

References

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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.

Reference Type DERIVED
PMID: 30242825 (View on PubMed)

Other Identifiers

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TJ-1

Identifier Type: -

Identifier Source: org_study_id