The Various Effects of Gaseous Albuterol on Serum Lactate

NCT02073747 | Completed Results

• 1 other identifier: EM 2014.01
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Keywords

Albuterol; Serum Lactate; Lactic Acidosis; Asthma

Outcome Measures

Primary Outcomes (1)

• Number of Subjects With a Change From Baseline Serum Lactate Following a One Hour Albuterol Nebulizer Treatment.

  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.

  Change in serum lactate from baseline to 1 hour

Study Arms (2)

Normal Saline Control Group

PLACEBO COMPARATOR

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

Drug: Normal Saline

Albuterol Trial Group

ACTIVE COMPARATOR

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

Drug: Albuterol

Interventions

Normal Saline DRUG

One hour inhaled normal saline

Also known as: NS, Saline

Normal Saline Control Group

Albuterol DRUG

One hour inhaled ten milligrams of albuterol

Also known as: Ventilin, Proventil

Albuterol Trial Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older

You may not qualify if:

• 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

Sponsors & Collaborators

• University Medical Center of Southern Nevada: lead

Study Sites (1)

University Medical Center of Southern Nevada

Las Vegas, Nevada, 89102, United States

Location

Related 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. doi: 10.1016/0002-9343(83)90436-9.

  PMID: 6414303 BACKGROUND

• 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.

  PMID: 778959 BACKGROUND

• 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.

  PMID: 11348975 BACKGROUND

• 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.

  PMID: 9187208 BACKGROUND

• 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.

  PMID: 17349773 BACKGROUND

• 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.

  PMID: 15911945 BACKGROUND

MeSH Terms

Conditions

Asthma; Acidosis, Lactic

Interventions

Saline Solution; Sodium Chloride; Albuterol

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Acidosis; Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines

Results Point of Contact

• Title: Emergency Department Research Coordinator
• Organization: University Medical Center of Southern Nevada

wesley.forred@umcsn.com

702-224-7124

Study Officials

• Tony Zitek, MD

  Emergency Medicine Residency Faculty

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 19, 2014
• First Posted: February 27, 2014
• Study Start: April 1, 2015
• Primary Completion: July 1, 2015
• Study Completion: August 1, 2015
• Last Updated: August 14, 2017
• Results First Posted: August 14, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)