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The Various Effects of Gaseous Albuterol on Serum Lactate

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02073747
Recruitment Status : Completed
First Posted : February 27, 2014
Results First Posted : August 14, 2017
Last Update Posted : August 14, 2017
Sponsor:
Information provided by (Responsible Party):
Joseph Anthony Zitek, University Medical Center of Southern Nevada

Study Description
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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 Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
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 : April 2015
Actual Primary Completion Date : July 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arms and Interventions
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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
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Primary Outcome Measures :
  1. Number of Subjects With a Change From Baseline Serum Lactate Following a One Hour Albuterol Nebulizer Treatment. [ Time Frame: 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
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02073747


Locations
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United States, Nevada
University Medical Center of Southern Nevada
Las Vegas, Nevada, United States, 89102
Sponsors and Collaborators
University Medical Center of Southern Nevada
Investigators
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Principal Investigator: Tony Zitek, MD Emergency Medicine Residency Faculty
More Information
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Publications:

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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: February 27, 2014    Key Record Dates
Results First Posted: August 14, 2017
Last Update Posted: August 14, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No IPD will be shared.
Keywords provided by Joseph Anthony Zitek, University Medical Center of Southern Nevada:
Albuterol
Serum Lactate
Lactic Acidosis
Asthma
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Albuterol
Bronchodilator Agents
Autonomic Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action