Effect of Nebulized Bronchodilators on Heart Rate

This study has been completed.
Sponsor:
Information provided by:
Genesys Regional Medical Center
ClinicalTrials.gov Identifier:
NCT01151579
First received: June 24, 2010
Last updated: July 14, 2010
Last verified: May 2010
  Purpose

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 Intervention Phase
COPD
CABG Surgery
Sepsis
Shock
Ventilators, Mechanical
Drug: Levalbuterol
Drug: Albuterol
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Official Title: Prospective Trial of Effect of Nebulized Bronchodilators on Heart Rate and Arrhythmias in Critically Ill Adult Patients

Resource links provided by NLM:


Further study details as provided by Genesys Regional Medical Center:

Primary Outcome Measures:
  • Average difference in Heart rate between pre and post breathing treatments [ Time Frame: Five days ] [ Designated as safety issue: Yes ]
    Heart rate in beats per minute


Secondary Outcome Measures:
  • Arrhythmias [ Time Frame: 15 minutes after each treatment for average of 3 to 5 days ] [ Designated as safety issue: Yes ]
    Any new arrhythmia documented in the medical record that occurred between study treatments.

  • Total number arrhythmias [ Time Frame: Five days ] [ Designated as safety issue: Yes ]
    Documented new arrhythmia occurring during study.


Enrollment: 70
Study Start Date: December 2008
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Nebulized albuterol 2.5mg
Patients were randomized to receive an initial dose of albuterol 2.5 mg alternating with levalbuterol 0.63 mg.
Drug: Albuterol
Nebulized albuterol 2.5mg
Other Name: Salbutamol
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
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

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 levalbuterol 0.63 mg alternating with albuterol 2.5 mg. Group C received levalbuterol 1.25 mg alternating with albuterol 2.5 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01151579

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

No publications provided by Genesys Regional Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Fahim Khorfan, MD, Pulmonologist, Genesys Regional Medical Center
ClinicalTrials.gov Identifier: NCT01151579     History of Changes
Other Study ID Numbers: ME 07-0011
Study First Received: June 24, 2010
Last Updated: July 14, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by 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
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 22, 2014