The Various Effects of Gaseous Albuterol on Serum Lactate

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Various Effects of Gaseous Albuterol on Serum Lactate

Conditions
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Asthma

Intervention / Treatment
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* Drug: Normal Saline
* Drug: Albuterol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years or older Exclusion Criteria: Pregnant Prisoner beta agonist allergy hypokalemia taking furosemide, insulin, thiazide diuretics, metformin or acetazolamide coronary artery disease hyperthyroidism abnormal heart rhythm baseline serum lactate level >2.2 mmol/L baseline heart rate > 120

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Normal Saline Control Group<br>Control group will be administered a one hour normal saline inhaled treatment. | Drug: Normal Saline<br>* One hour inhaled normal saline<br>* Other names: Saline;|
| Active Comparator: Albuterol Trial Group<br>Trial group to be administered one hour treatment of ten milligrams of inhaled albuterol | Drug: Albuterol<br>* One hour inhaled ten milligrams of albuterol<br>* Other names: Proventil;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects With a Change From Baseline Serum Lactate Following a One Hour Albuterol Nebulizer Treatment. | 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. | Change in serum lactate from baseline to 1 hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Albuterol, Serum Lactate, Lactic Acidosis, Asthma