Effect of Nebulized Bronchodilators on Heart Rate

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

89 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2009-11-30

Brief Summary

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The purpose of the study is to determine adverse events rates of nebulized albuterol versus levalbuterol among adult critically ill patients and determine if a differential exists in adverse events between the two drugs.

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Detailed Description

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A randomized, single-blind, cross-over, prospective study was conducted in seventy critically ill adult patients with acute air flow obstruction. Patients were randomized to nebulized albuterol alternating with levalbuterol every 4 to 6 hours. Group A received albuterol 2.5 mg alternating with levalbuterol 0.63 mg. Group B received albuterol 2.5 mg alternating with levalbuterol 1.25 mg. All patients received nebulized ipratropium bromide 500 micrograms with each treatment. Heart rate and cardiac rhythm were continuously recorded before and 15 minutes after finishing each treatment. Any new rhythm abnormalities between treatments were also recorded.

Conditions

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COPD Sepsis Shock

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Levalbuterol 0.63

Patients received an initial dose of levalbuterol 0.63 mg alternating with albuterol 2.5 mg.

Group Type ACTIVE_COMPARATOR

Levalbuterol

Intervention Type DRUG

inhaled Levalbuterol 0.625 mg inhaled Levalbuterol 2.5 mg

Albuterol

Intervention Type DRUG

Nebulized albuterol 2.5mg

Levalbuterol 1.25

Patients received an initial dose of levalbuterol 1.25 mg alternating with albuterol 2.5 mg.

Group Type ACTIVE_COMPARATOR

Levalbuterol

Intervention Type DRUG

inhaled Levalbuterol 0.625 mg inhaled Levalbuterol 2.5 mg

Albuterol

Intervention Type DRUG

Nebulized albuterol 2.5mg

Interventions

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Levalbuterol

inhaled Levalbuterol 0.625 mg inhaled Levalbuterol 2.5 mg

Intervention Type DRUG

Albuterol

Nebulized albuterol 2.5mg

Intervention Type DRUG

Other Intervention Names

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Xopenex ipratropium Salbutamol

Eligibility Criteria

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Inclusion Criteria

* Adults who required inhaled bronchodilator therapy in the form of short acting beta adrenergic receptor agonist and short acting anti-cholinergic treatment every 4-6 hours for respiratory functions