Effect of Nebulized Bronchodilators on Heart Rate

September 23, 2015 updated by: Fahim Khorfan, MD

Prospective Trial of Effect of Nebulized Bronchodilators on Heart Rate and Arrhythmias in Critically Ill Adult Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

89

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Grand Blanc, Michigan, United States, 48439
        • Genesys Regional Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Salbutamol

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
15 minutes after each treatment for average of 3 to 5 days
Total Number of Participants With Arrhythmias
Time Frame: Five days
Documented new arrhythmia occurring during study.
Five days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fahim Khorfan, MD

Collaborators

Ascension Genesys Hospital

Investigators

  • Principal Investigator: Fahim Khorfan, MD, Ascension Genesys Hospital
  • Study Director: Kimberly R Barber, PhD, Ascension Genesys Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (Actual)

November 1, 2009

Study Completion (Actual)

November 1, 2009

Study Registration Dates

First Submitted

June 24, 2010

First Submitted That Met QC Criteria

June 25, 2010

First Posted (Estimate)

June 28, 2010

Study Record Updates

Last Update Posted (Estimate)

October 23, 2015

Last Update Submitted That Met QC Criteria

September 23, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ME 07-0011

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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