The Various Effects of Gaseous Albuterol on Serum Lactate

University Medical Center of Southern Nevada

Status: Completed

Conditions: Asthma

Treatments: Drug: Normal Saline; Drug: Albuterol

Study type: Interventional

Funder types: Other

Identifiers

NCT02073747

EM 2014.01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 28 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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28 participants in 2 patient groups, including a placebo group

Normal Saline Control Group

Placebo Comparator group

Description:

Control group will be administered a one hour normal saline inhaled treatment.

Treatment:

Drug: Normal Saline

Albuterol Trial Group

Active Comparator group

Description:

Trial group to be administered one hour treatment of ten milligrams of inhaled albuterol

Treatment:

Drug: Albuterol