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Completed

NCT Number: NCT01151579

Effect of Nebulized Bronchodilators on Heart Rate

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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Key information

Conditions

COPD Arrhythmias, Cardiac Cardiac Conduction System Disease Cardiovascular Diseases Chronic Disease Disease Attributes Heart Diseases Infections Inflammation Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases Sepsis Shock Systemic Inflammatory Response Syndrome Tachycardia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Genesys Regional Medical Center

Grand Blanc, Michigan, 48439, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Exclusion criteria

  • Known allergy or sensitivity to study medications
  • Baseline heart rate was greater than 110 beats per minute

Treatment and study plan

Levalbuterol

Drug

inhaled Levalbuterol 0.625 mg inhaled Levalbuterol 2.5 mg

Other names: Xopenex, ipratropium

albuterol

Drug

Nebulized albuterol 2.5mg

Other names: Salbutamol

Primary outcomes

  1. Heart Rate in Beats Per Minute

    Time frame: Five days

    Average difference in Heart rate between pre and post breathing treatments

Secondary outcomes

  1. Arrhythmias

    Time frame: 15 minutes after each treatment for average of 3 to 5 days

    Any new arrhythmia documented in the medical record that occurred between breathing treatments.

  2. Total Number of Participants With Arrhythmias

    Time frame: Five days

    Documented new arrhythmia occurring during study.

Sponsors and collaborators

Lead sponsor

Fahim Khorfan, MD

Industry

Collaborators

  • Ascension Health

Registry information

Official study title

Prospective Trial of Effect of Nebulized Bronchodilators on Heart Rate and Arrhythmias in Critically Ill Adult Patients

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jun 28, 2010
Registry last updated
Oct 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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