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
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|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||28 participants|
|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|
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
Active Comparator: Albuterol Trial Group
Trial group to be administered one hour treatment of ten milligrams of inhaled albuterol
One hour inhaled ten milligrams of albuterol
- 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.
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
|United States, Nevada|
|University Medical Center of Southern Nevada|
|Las Vegas, Nevada, United States, 89102|
|Principal Investigator:||Tony Zitek, MD||Emergency Medicine Residency Faculty|