Effect of Nebulized Bronchodilators on Heart Rate
Information source: Genesys Regional Medical Center
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: COPD; CABG Surgery; Sepsis; Shock; Ventilators, Mechanical
Intervention: Levalbuterol (Drug); Albuterol (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Genesys Regional Medical Center Official(s) and/or principal investigator(s): Fahim Khorfan, MD, Principal Investigator, Affiliation: Genesys Regional Medical Center Kimberly R Barber, PhD, Study Director, Affiliation: Genesys Regional Medical Center
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.
Clinical Details
Official title: Prospective Trial of Effect of Nebulized Bronchodilators on Heart Rate and Arrhythmias in Critically Ill Adult Patients
Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care
Primary outcome: Average difference in Heart rate between pre and post breathing treatments
Secondary outcome: ArrhythmiasTotal number arrhythmias
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Genesys Regional Medical Center, Grand Blanc, Michigan 48439, United States
Additional Information
Starting date: December 2008
Last updated: July 14, 2010
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