The Various Effects of Gaseous Albuterol on Serum Lactate

• Sponsor: University Medical Center of Southern Nevada (Other)
• Overall Status: Completed
• CT.gov ID: NCT02073747
• Collaborator: (none)
• Enrollment: 28
• Location: 1
• Arms: 2
• Duration (Months): 4
• Patients Per Site Per Month: 7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Asthma	Drug: Normal Saline; Drug: Albuterol	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 28 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Health Services Research
• Official Title: The Various Effects of Gaseous Albuterol on Serum Lactate
• Study Start Date: Apr 1, 2015
• Actual Primary Completion Date: Jul 1, 2015
• Actual Study Completion Date: Aug 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Normal Saline Control Group Control group will be administered a one hour normal saline inhaled treatment.	Drug: Normal Saline; One hour inhaled normal saline; Other Names: NS Saline
Active Comparator: Albuterol Trial Group Trial group to be administered one hour treatment of ten milligrams of inhaled albuterol	Drug: Albuterol; One hour inhaled ten milligrams of albuterol; Other Names: Ventilin Proventil

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Medical Center of Southern Nevada	Las Vegas	Nevada	United States	89102

Sponsors and Collaborators

• University Medical Center of Southern Nevada

Investigators

• Principal Investigator: Tony Zitek, MD, Emergency Medicine Residency Faculty

Study Documents (Full-Text)

None provided.

More Information

Publications

• Appel D, Rubenstein R, Schrager K, Williams MH Jr. Lactic acidosis in severe asthma. Am J Med. 1983 Oct;75(4):580-4.
• 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.
• Manthous CA. Lactic acidosis in status asthmaticus : three cases and review of the literature. Chest. 2001 May;119(5):1599-602. Review.
• Maury E, Ioos V, Lepecq B, Guidet B, Offenstadt G. A paradoxical effect of bronchodilators. Chest. 1997 Jun;111(6):1766-7. Review.
• 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.
• Roncoroni AJ, Adrougué HJ, De Obrutsky CW, Marchisio ML, Herrera MR. Metabolic acidosis in status asthmaticus. Respiration. 1976;33(2):85-94.

• Responsible Party: Joseph Anthony Zitek, MD, University Medical Center of Southern Nevada
• ClinicalTrials.gov Identifier: NCT02073747
• Other Study ID Numbers: EM 2014.01
• First Posted: Feb 27, 2014
• Last Update Posted: Aug 14, 2017
• Last Verified: Jul 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Joseph Anthony Zitek, MD, University Medical Center of Southern Nevada: Albuterol; Serum Lactate; Lactic Acidosis; Asthma
• Additional relevant MeSH terms: Asthma; Albuterol

Study Results

Participant Flow

Recruitment Details	Healthy volunteers were recruited from the investigators' friends and family.

Arm/Group Title	Normal Saline Control Group	Albuterol Trial Group
Arm/Group Description	Control group will be administered a one hour normal saline inhaled treatment. Normal Saline: One hour inhaled normal saline	Trial group to be administered one hour treatment of ten milligrams of inhaled albuterol Albuterol: One hour inhaled ten milligrams of albuterol
Period Title: Overall Study
STARTED	15	15
COMPLETED	14	14
NOT COMPLETED	1	1

Baseline Characteristics

Arm/Group Title	Albuterol	Normal Saline	Total
Arm/Group Description	Study group	Control group	Total of all reporting groups
Overall Participants	14	14	28
Age (years) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [years]	29	28	28.5
Sex: Female, Male (Count of Participants)
Female	4 28.6%	7 50%	11 39.3%
Male	10 71.4%	7 50%	17 60.7%
Region of Enrollment (Count of Participants)
United States	14 100%	14 100%	28 100%

Outcome Measures

1. Primary Outcome

Title	Number of Subjects With a Change From Baseline Serum Lactate Following a One Hour Albuterol Nebulizer Treatment.
Description	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.
Time Frame	Change in serum lactate from baseline to 1 hour

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Normal Saline Control Group	Albuterol Trial Group
Arm/Group Description	Control group will be administered a one hour normal saline inhaled treatment. Normal Saline: One hour inhaled normal saline	Trial group to be administered one hour treatment of ten milligrams of inhaled albuterol Albuterol: One hour inhaled ten milligrams of albuterol
Measure Participants	14	14
Mean (95% Confidence Interval) [mmol/L]	-0.15	0.77

Adverse Events

Arm/Group Title	Albuterol		Normal Saline
Arm/Group Description	Study group; 10 mg of nebulizer albuterol		Control group
All Cause Mortality
	Albuterol		Normal Saline
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/14 (0%)		0/14 (0%)
Serious Adverse Events
	Albuterol		Normal Saline
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/14 (0%)		0/14 (0%)
Other (Not Including Serious) Adverse Events
	Albuterol		Normal Saline
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/14 (0%)		0/14 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.