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The Various Effects of Gaseous Albuterol on Serum Lactate

Primary Purpose

Asthma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Normal Saline
Albuterol
Sponsored by
University Medical Center of Southern Nevada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Asthma focused on measuring Albuterol, Serum Lactate, Lactic Acidosis, Asthma

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University Medical Center of Southern Nevada

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Normal Saline Control Group

Albuterol Trial Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
February 19, 2014
Last Updated
July 13, 2017
Sponsor
University Medical Center of Southern Nevada
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1. Study Identification

Unique Protocol Identification Number
NCT02073747
Brief Title
The Various Effects of Gaseous Albuterol on Serum Lactate
Official Title
The Various Effects of Gaseous Albuterol on Serum Lactate
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Medical Center of Southern Nevada

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Albuterol, Serum Lactate, Lactic Acidosis, Asthma

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Non-Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Normal Saline Control Group
Arm Type
Placebo Comparator
Arm Description
Control group will be administered a one hour normal saline inhaled treatment.
Arm Title
Albuterol Trial Group
Arm Type
Active Comparator
Arm Description
Trial group to be administered one hour treatment of ten milligrams of inhaled albuterol
Intervention Type
Drug
Intervention Name(s)
Normal Saline
Other Intervention Name(s)
NS, Saline
Intervention Description
One hour inhaled normal saline
Intervention Type
Drug
Intervention Name(s)
Albuterol
Other Intervention Name(s)
Ventilin, Proventil
Intervention Description
One hour inhaled ten milligrams of albuterol
Primary Outcome Measure Information:
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tony Zitek, MD
Organizational Affiliation
Emergency Medicine Residency Faculty
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Medical Center of Southern Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No IPD will be shared.
Citations:
PubMed Identifier
6414303
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.
Results Reference
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PubMed Identifier
778959
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.
Results Reference
background
PubMed Identifier
11348975
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.
Results Reference
background
PubMed Identifier
9187208
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.
Results Reference
background
PubMed Identifier
17349773
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.
Results Reference
background
PubMed Identifier
15911945
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.
Results Reference
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The Various Effects of Gaseous Albuterol on Serum Lactate

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