Effect of Nebulized Bronchodilators on Heart Rate

Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01151579
• Other study ID #: ME 07-0011
• Status: Completed
• Phase: Phase 4
• First received: June 24, 2010
• Last updated: September 23, 2015
• Start date: December 2008
• Est. completion date: November 2009

Study information

• Verified date: September 2015
• Source: Genesys Regional Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• COPD
• Sepsis
• Shock

Intervention

Drug:
• Levalbuterol
inhaled Levalbuterol 0.625 mg inhaled Levalbuterol 2.5 mg
• Albuterol
Nebulized albuterol 2.5mg

Locations

Country	Name	City	State
United States	Genesys Regional Medical Center	Grand Blanc	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Fahim Khorfan, MD	Genesys Regional Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart Rate in Beats Per Minute	Average difference in Heart rate between pre and post breathing treatments	Five days	Yes
Secondary	Arrhythmias	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	Yes
Secondary	Total Number of Participants With Arrhythmias	Documented new arrhythmia occurring during study.	Five days	Yes