The Various Effects of Gaseous Albuterol on Serum Lactate

Asthma Clinical Trial

Official title:

The Various Effects of Gaseous Albuterol on Serum Lactate

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02073747
• Other study ID #: EM 2014.01
• Status: Completed
• Phase: N/A
• First received: February 19, 2014
• Last updated: October 26, 2016
• Start date: April 2015
• Est. completion date: August 2015

Study information

• Verified date: January 2016
• Source: University Medical Center of Southern Nevada
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: August 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Normal Saline
One hour inhaled normal saline
• Albuterol
One hour inhaled ten milligrams of albuterol

Locations

Country	Name	City	State
United States	University Medical Center of Southern Nevada	Las Vegas	Nevada

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center of Southern Nevada

Country where clinical trial is conducted

United States, 

References & Publications (6)

Appel D, Rubenstein R, Schrager K, Williams MH Jr. Lactic acidosis in severe asthma. Am J Med. 1983 Oct;75(4):580-4. — View Citation

Chaulier K, Chalumeau S, Ber CE, Bret M, Rimmelé T. [Metabolic acidosis in a context of acute severe asthma]. Ann Fr Anesth Reanim. 2007 Apr;26(4):352-5. Epub 2007 Mar 8. French. — View Citation

Manthous CA. Lactic acidosis in status asthmaticus : three cases and review of the literature. Chest. 2001 May;119(5):1599-602. Review. — View Citation

Maury E, Ioos V, Lepecq B, Guidet B, Offenstadt G. A paradoxical effect of bronchodilators. Chest. 1997 Jun;111(6):1766-7. Review. — View 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. — View Citation

Roncoroni AJ, Adrougué HJ, De Obrutsky CW, Marchisio ML, Herrera MR. Metabolic acidosis in status asthmaticus. Respiration. 1976;33(2):85-94. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of subjects with a change from baseline serum lactate following a one hour albuterol nebulizer treatment.		Change in serum lactate from baseline at 15 min, 30 min, 45 min and 1 hour	No