Clinical trial NCT02073747: The Various Effects of Gaseous Albuterol on Serum Lactate
Official title: The Various Effects of Gaseous Albuterol on Serum Lactate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Keywords: Albuterol
Serum Lactate
Lactic Acidosis
Asthma
Lead sponsor: University Medical Center of Southern Nevada
Sponsor class: OTHER
First posted: 2014-02-27
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Subjects With a Change From Baseline Serum Lactate Following a One Hour Albuterol Nebulizer Treatment.
timeFrame: Change in serum lactate from baseline to 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Las Vegas
country: United States
facility: University Medical Center of Southern Nevada
state: Nevada
Study officials:
affiliation: Emergency Medicine Residency Faculty
name: Tony Zitek, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Appel D, Rubenstein R, Schrager K, Williams MH Jr. Lactic acidosis in severe asthma. Am J Med. 1983 Oct;75(4):580-4. doi: 10.1016/0002-9343(83)90436-9.
citation: Roncoroni AJ, Adrougue HJ, De Obrutsky CW, Marchisio ML, Herrera MR. Metabolic acidosis in status asthmaticus. Respiration. 1976;33(2):85-94. doi: 10.1159/000193721.
citation: Manthous CA. Lactic acidosis in status asthmaticus : three cases and review of the literature. Chest. 2001 May;119(5):1599-602. doi: 10.1378/chest.119.5.1599.
citation: Maury E, Ioos V, Lepecq B, Guidet B, Offenstadt G. A paradoxical effect of bronchodilators. Chest. 1997 Jun;111(6):1766-7. doi: 10.1378/chest.111.6.1766.
citation: Chaulier K, Chalumeau S, Ber CE, Bret M, Rimmele T. [Metabolic acidosis in a context of acute severe asthma]. Ann Fr Anesth Reanim. 2007 Apr;26(4):352-5. doi: 10.1016/j.annfar.2007.01.016. Epub 2007 Mar 8. French.
citation: Rodrigo GJ, Rodrigo C. Elevated plasma lactate level associated with high dose inhaled albuterol therapy in acute severe asthma. Emerg Med J. 2005 Jun;22(6):404-8. doi: 10.1136/emj.2003.012039.