University Medical Center of Southern Nevada
Las Vegas, Nevada, 89102, United States
NCT Number: NCT02073747
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.
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Notify Me18 year–70 year
All sexes
Interventional
Not applicable
Las Vegas, Nevada, 89102, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
One hour inhaled normal saline
Other names: NS, Saline
One hour inhaled ten milligrams of albuterol
Other names: Ventilin, Proventil
Time frame: Change in serum lactate from baseline to 1 hour
We powered our study to detect a difference of 0.5 mmol/L between pre and post-treatment lactate levels, but hypothesize that the difference will be greater than 1.0 mmol/L.
University Medical Center of Southern Nevada
Other
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