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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal Saline Control Group | Placebo Comparator | Control group will be administered a one hour normal saline inhaled treatment. |
|
| Albuterol Trial Group | Active Comparator | Trial group to be administered one hour treatment of ten milligrams of inhaled albuterol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Normal Saline | Drug | One hour inhaled normal saline |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Change in serum lactate from baseline to 1 hour |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tony Zitek, MD | Emergency Medicine Residency Faculty | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center of Southern Nevada | Las Vegas | Nevada | 89102 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 6414303 | Background | 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. | |
| 778959 | Background | 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. |
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No IPD will be shared.
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Healthy volunteers were recruited from the investigators' friends and family.
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| ID | Title | Description |
|---|---|---|
| FG000 | Normal Saline Control Group | Control group will be administered a one hour normal saline inhaled treatment. Normal Saline: One hour inhaled normal saline |
| FG001 | Albuterol Trial Group | Trial group to be administered one hour treatment of ten milligrams of inhaled albuterol Albuterol: One hour inhaled ten milligrams of albuterol |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Albuterol | Study group |
| BG001 | Normal Saline | Control group |
| BG002 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | 95% Confidence Interval | mmol/L | Change in serum lactate from baseline to 1 hour |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Albuterol | Study group; 10 mg of nebulizer albuterol | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Emergency Department Research Coordinator | University Medical Center of Southern Nevada | 702-224-7124 | wesley.forred@umcsn.com |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| D000140 | Acidosis, Lactic |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| D012965 | Sodium Chloride |
| D000420 | Albuterol |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| Albuterol | Drug | One hour inhaled ten milligrams of albuterol |
|
|
| 11348975 | Background | 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. |
| 9187208 | Background | 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. |
| 17349773 | Background | 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. |
| 15911945 | Background | 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. |
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| 14 |
| 0 |
| 14 |
| 0 |
| 14 |
| EG001 | Normal Saline | Control group | 0 | 14 | 0 | 14 | 0 | 14 |
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| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D000138 | Acidosis |
| D000137 | Acid-Base Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D002712 |
| Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |