NCT02073747

The Various Effects of Gaseous Albuterol on Serum Lactate

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: University Medical Center of Southern Nevada · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

Empirical data from physician observation indicates an increase in serum lactate in acute asthmatic patients being treated with inhaled albuterol therapy. It is not clear if this increased serum lactate is in response to a physiological response to the asthmatic process or from the albuterol treatment. This study is designed to determine if administration of inhaled albuterol increases serum lactate in healthy subjects.

Detailed description

Approximately 30 healthy volunteers will be randomized to Albuterol or placebo. We powered our study to detect a difference of 0.5 mmol/L, but hypothesize that the difference will be greater than 1.0 mmol/L. All volunteer subjects will sign a written consent, approved by the Institutional Review Board. The intended pool of volunteers will be from residents, attendings, and medical students in the hospital. The consent form will clearly specify that their participation in the study will not impact their academic status or employment. The subjects randomized to the Albuterol arm will receive a one hour 10 mg continuous Albuterol nebulizer treatment. Those randomized to placebo will receive a one-hour saline nebulizer treatment. The chief pharmacist for the study will randomly assign a number between one and thirty to fifteen Albuterol treatments and fifteen placebo treatments. Subjects will be monitored with cardiac monitor and serum lactate levels will be drawn every 15 minutes.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	Normal Saline	One hour inhaled normal saline
DRUG	Albuterol	One hour inhaled ten milligrams of albuterol

Timeline

• Start date: 2015-04-01
• Primary completion: 2015-07-01
• Completion: 2015-08-01
• First posted: 2014-02-27
• Last updated: 2017-08-14
• Results posted: 2017-08-14

Locations

1 site across 1 country: United States