The Various Effects of Gaseous Albuterol on Serum Lactate

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2015-08-31

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.

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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.

Conditions

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Asthma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Normal Saline Control Group

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

Group Type PLACEBO_COMPARATOR

Normal Saline

Intervention Type DRUG

One hour inhaled normal saline

Albuterol Trial Group

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

Group Type ACTIVE_COMPARATOR

Albuterol

Intervention Type DRUG

One hour inhaled ten milligrams of albuterol

Interventions

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Normal Saline

One hour inhaled normal saline

Intervention Type DRUG

Albuterol

One hour inhaled ten milligrams of albuterol

Intervention Type DRUG

Other Intervention Names

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NS Saline Ventilin Proventil

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes