Effect of Nebulized Bronchodilators on Heart Rate

Overview

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.

Full Title of Study: “Prospective Trial of Effect of Nebulized Bronchodilators on Heart Rate and Arrhythmias in Critically Ill Adult Patients”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Supportive Care
    • Masking: Single (Participant)
  • Study Primary Completion Date: November 2009

Detailed Description

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.

Interventions

  • Drug: Levalbuterol
    • inhaled Levalbuterol 0.625 mg inhaled Levalbuterol 2.5 mg
  • Drug: Albuterol
    • Nebulized albuterol 2.5mg

Arms, Groups and Cohorts

  • Active Comparator: Levalbuterol 0.63
    • Patients received an initial dose of levalbuterol 0.63 mg alternating with albuterol 2.5 mg.
  • Active Comparator: Levalbuterol 1.25
    • Patients received an initial dose of levalbuterol 1.25 mg alternating with albuterol 2.5 mg.

Clinical Trial Outcome Measures

Primary Measures

  • Heart Rate in Beats Per Minute
    • Time Frame: Five days
    • Average difference in Heart rate between pre and post breathing treatments

Secondary Measures

  • 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.
  • Total Number of Participants With Arrhythmias
    • Time Frame: Five days
    • Documented new arrhythmia occurring during study.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Fahim Khorfan, MD
  • Collaborator
    • Ascension Health
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Fahim Khorfan, MD, ICU Pulmonologist – Ascension Health
  • Overall Official(s)
    • Fahim Khorfan, MD, Principal Investigator, Ascension Health
    • Kimberly R Barber, PhD, Study Director, Ascension Health

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