The Various Effects of Gaseous Albuterol on Serum Lactate

Not Applicable

Completed

• Conditions: Asthma
• Interventions: Drug: Normal Saline; Drug: Albuterol

• Registration Number: NCT02073747
• Lead Sponsor: University Medical Center of Southern Nevada

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.

Study Timeline

• Study First Submitted: 2014-02-19
• Study First Submitted QC: 2014-02-25
• Study First Posted: 2014-02-27
• Study Start: 2015-04
• Primary Completion: 2015-07
• Study Completion: 2015-08
• Results First Submitted: 2017-06-10
• Status Verified: 2017-07
• Results First Submitted QC: 2017-07-13
• Last Update Submitted: 2017-07-13
• Results First Posted: 2017-08-14
• Last Update Posted: 2017-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal Saline Control Group	Normal Saline	Control group will be administered a one hour normal saline inhaled treatment.
Albuterol Trial Group	Albuterol	Trial group to be administered one hour treatment of ten milligrams of inhaled albuterol

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

University Medical Center of Southern Nevada; 🇺🇸 Las Vegas, Nevada, United States