The Various Effects of Gaseous Albuterol on Serum Lactate
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Number of Subjects With a Change From Baseline Serum Lactate Following a One Hour Albuterol Nebulizer Treatment.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 years or older
排除标准
- •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
研究组 & 干预措施
Normal Saline Control Group
Control group will be administered a one hour normal saline inhaled treatment.
干预措施: Normal Saline (Drug)
Albuterol Trial Group
Trial group to be administered one hour treatment of ten milligrams of inhaled albuterol
干预措施: Albuterol (Drug)
结局指标
主要结局
Number of Subjects With a Change From Baseline Serum Lactate Following a One Hour Albuterol Nebulizer Treatment.
时间窗: 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.
次要结局
未报告次要终点
研究者
Joseph Anthony Zitek
MD
University Medical Center of Southern Nevada