NCT01714401

Brief 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. 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2012

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 23, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 25, 2012

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2013

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2013

Completed
Last Updated

December 14, 2018

Status Verified

December 1, 2018

Enrollment Period

1.2 years

First QC Date

October 23, 2012

Last Update Submit

December 12, 2018

Conditions

Influence of Nebulized Bronchodilatators on SelectedElectrophysiological Parameters

Outcome Measures

Primary Outcomes (4)

  • QT interval

    changes of QT interval after salbutamol nebulisation

    one hour

  • corrected QT (QTc) interval using Bazett's (QTcB) correction

    changes of QTc interval after salbutamol nebulisation

    one hour

  • corrected QT (QTc) interval using Framingham (QTcF) correction

    changes of QTc interval after salbutamol nebulisation

    one hour

  • Tpeak-Tend

    changes in transmural dispersion of repolarization after salbutamol nebulisation

    one hour

Study Arms (2)

Salbutamol 2,5 mg

ACTIVE COMPARATOR

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

Drug: Salbutamol 2,5 mg

Salbutamol 5mg

ACTIVE COMPARATOR

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

Drug: Salbutamol 5mg

Interventions

Salbutamol 2,5 mgDRUG

20 min nebulization of 2.5 mg of salbutamol

Also known as: Ventolin 2.5mg
Salbutamol 2,5 mg
Salbutamol 5mgDRUG

20 min nebulization of 5 mg of salbutamol

Also known as: Ventolin 5mg
Salbutamol 5mg

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • the necessity of b2 adrenergics an m2 mimetics administration

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Medical University of Gdansk - Departament of Anesthesiolog and Intensive cCre

Gdansk, 80-214, Poland

Location

Medical University of Gdańsk - Departament of Anesthesiology and Intensive Care

Gdansk, 80-214, Poland

Location

Related Publications (1)

  • 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.

    PMID: 30242825DERIVED

MeSH Terms

Interventions

Albuterol

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesPhenethylaminesEthylamines

Study Officials

  • Tomasz Jasiński, MD

    Medical University of Gdansk

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

October 23, 2012

First Posted

October 25, 2012

Study Start

March 1, 2012

Primary Completion

May 30, 2013

Study Completion

December 31, 2013

Last Updated

December 14, 2018

Record last verified: 2018-12

Locations

PL(2)