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OpenTrials
Completed

NCT Number: NCT02073747

The Various Effects of Gaseous Albuterol on Serum Lactate

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Medical Center of Southern Nevada

Las Vegas, Nevada, 89102, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

normal saline

Drug

One hour inhaled normal saline

Other names: NS, Saline

albuterol

Drug

One hour inhaled ten milligrams of albuterol

Other names: Ventilin, Proventil

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

University Medical Center of Southern Nevada

Other

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Feb 27, 2014
Registry last updated
Aug 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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