Effect of Nebulized Bronchodilators on Heart Rate

Phase 4

Completed

• Conditions: Sepsis; COPD; Shock
• Interventions: Drug: Levalbuterol; Drug: Albuterol

• Registration Number: NCT01151579
• Lead Sponsor: Fahim Khorfan, MD

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.

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 Timeline

• Study Start: 2008-12
• Primary Completion: 2009-11
• Study Completion: 2009-11
• Study First Submitted: 2010-06-24
• Study First Submitted QC: 2010-06-25
• Study First Posted: 2010-06-28
• Results First Submitted: 2015-03-12
• Status Verified: 2015-09
• Results First Submitted QC: 2015-09-23
• Last Update Submitted: 2015-09-23
• Results First Posted: 2015-10-23
• Last Update Posted: 2015-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 89

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Levalbuterol 0.63	Levalbuterol	Patients received an initial dose of levalbuterol 0.63 mg alternating with albuterol 2.5 mg.
Levalbuterol 1.25	Levalbuterol	Patients received an initial dose of levalbuterol 1.25 mg alternating with albuterol 2.5 mg.
Levalbuterol 0.63	Albuterol	Patients received an initial dose of levalbuterol 0.63 mg alternating with albuterol 2.5 mg.
Levalbuterol 1.25	Albuterol	Patients received an initial dose of levalbuterol 1.25 mg alternating with albuterol 2.5 mg.

Primary Outcome Measures

Name	Time	Method
Heart Rate in Beats Per Minute	Five days	Average difference in Heart rate between pre and post breathing treatments

Secondary Outcome Measures

Name	Time	Method
Arrhythmias	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	Five days	Documented new arrhythmia occurring during study.

Trial Locations

Locations (1)

Genesys Regional Medical Center; 🇺🇸 Grand Blanc, Michigan, United States