Asthma
Conditions
Keywords
Albuterol, Serum Lactate, Lactic Acidosis, Asthma
Brief 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.
Interventions
DRUGNormal Saline
One hour inhaled normal saline
DRUGAlbuterol
One hour inhaled ten milligrams of albuterol
Sponsors
University Medical Center of Southern Nevada
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With a Change From Baseline Serum Lactate Following a One Hour Albuterol Nebulizer Treatment. | 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. |
Countries
United States
Participant flow
Recruitment details
Healthy volunteers were recruited from the investigators' friends and family.
Participants by arm
| Arm | Count |
|---|---|
| Albuterol Study group | 14 |
| Normal Saline Control group | 14 |
| Total | 28 |
Baseline characteristics
| Characteristic | Albuterol | Normal Saline | Total |
|---|---|---|---|
| Age, Continuous | 29 years | 28 years | 28.5 years |
| Region of Enrollment United States | 14 Participants | 14 Participants | 28 Participants |
| Sex: Female, Male Female | 4 Participants | 7 Participants | 11 Participants |
| Sex: Female, Male Male | 10 Participants | 7 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 14 | 0 / 14 |
| other Total, other adverse events | 0 / 14 | 0 / 14 |
| serious Total, serious adverse events | 0 / 14 | 0 / 14 |
Outcome results
Primary
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.
Time frame: Change in serum lactate from baseline to 1 hour
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Normal Saline Control Group | Number of Subjects With a Change From Baseline Serum Lactate Following a One Hour Albuterol Nebulizer Treatment. | -0.15 mmol/L |
| Albuterol Trial Group | Number of Subjects With a Change From Baseline Serum Lactate Following a One Hour Albuterol Nebulizer Treatment. | 0.77 mmol/L |