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Effect of Nebulized Bronchodilators on Heart Rate

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ClinicalTrials.gov Identifier: NCT01151579
Recruitment Status : Completed
First Posted : June 28, 2010
Results First Posted : October 23, 2015
Last Update Posted : October 23, 2015
Sponsor:
Collaborator:
Genesys Regional Medical Center
Information provided by (Responsible Party):
Fahim Khorfan, MD, Genesys Regional Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
COPD Sepsis Shock Drug: Levalbuterol Drug: Albuterol Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 89 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Prospective Trial of Effect of Nebulized Bronchodilators on Heart Rate and Arrhythmias in Critically Ill Adult Patients
Study Start Date : December 2008
Actual Primary Completion Date : November 2009
Actual Study Completion Date : November 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Levalbuterol 0.63
Patients received an initial dose of levalbuterol 0.63 mg alternating with albuterol 2.5 mg.
Drug: Levalbuterol
inhaled Levalbuterol 0.625 mg inhaled Levalbuterol 2.5 mg
Other Names:
  • Xopenex
  • ipratropium

Drug: Albuterol
Nebulized albuterol 2.5mg
Other Name: Salbutamol

Active Comparator: Levalbuterol 1.25
Patients received an initial dose of levalbuterol 1.25 mg alternating with albuterol 2.5 mg.
Drug: Levalbuterol
inhaled Levalbuterol 0.625 mg inhaled Levalbuterol 2.5 mg
Other Names:
  • Xopenex
  • ipratropium

Drug: Albuterol
Nebulized albuterol 2.5mg
Other Name: Salbutamol




Primary Outcome Measures :
  1. Heart Rate in Beats Per Minute [ Time Frame: Five days ]
    Average difference in Heart rate between pre and post breathing treatments


Secondary Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01151579


Locations
United States, Michigan
Genesys Regional Medical Center
Grand Blanc, Michigan, United States, 48439
Sponsors and Collaborators
Fahim Khorfan, MD
Genesys Regional Medical Center
Investigators
Principal Investigator: Fahim Khorfan, MD Genesys Regional Medical Center
Study Director: Kimberly R Barber, PhD Genesys Regional Medical Center

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Fahim Khorfan, MD, ICU Pulmonologist, Genesys Regional Medical Center
ClinicalTrials.gov Identifier: NCT01151579     History of Changes
Other Study ID Numbers: ME 07-0011
First Posted: June 28, 2010    Key Record Dates
Results First Posted: October 23, 2015
Last Update Posted: October 23, 2015
Last Verified: September 2015

Keywords provided by Fahim Khorfan, MD, Genesys Regional Medical Center:
Tachycardia
tachyarrhythmias
bronchodilator therapy
Critically ill patients

Additional relevant MeSH terms:
Albuterol
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action