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| Name | Class |
|---|---|
| Ascension Health | INDUSTRY |
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The purpose of the study is to determine adverse events rates of nebulized albuterol versus levalbuterol among adult critically ill patients and determine if a differential exists in adverse events between the two drugs.
A randomized, single-blind, cross-over, prospective study was conducted in seventy critically ill adult patients with acute air flow obstruction. Patients were randomized to nebulized albuterol alternating with levalbuterol every 4 to 6 hours. Group A received albuterol 2.5 mg alternating with levalbuterol 0.63 mg. Group B received albuterol 2.5 mg alternating with levalbuterol 1.25 mg. All patients received nebulized ipratropium bromide 500 micrograms with each treatment. Heart rate and cardiac rhythm were continuously recorded before and 15 minutes after finishing each treatment. Any new rhythm abnormalities between treatments were also recorded.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Levalbuterol 0.63 | Active Comparator | Patients received an initial dose of levalbuterol 0.63 mg alternating with albuterol 2.5 mg. |
|
| Levalbuterol 1.25 | Active Comparator | Patients received an initial dose of levalbuterol 1.25 mg alternating with albuterol 2.5 mg. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levalbuterol | Drug | inhaled Levalbuterol 0.625 mg inhaled Levalbuterol 2.5 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Heart Rate in Beats Per Minute | Average difference in Heart rate between pre and post breathing treatments | Five days |
| Measure | Description | Time Frame |
|---|---|---|
| Arrhythmias | Any new arrhythmia documented in the medical record that occurred between breathing treatments. | 15 minutes after each treatment for average of 3 to 5 days |
| Total Number of Participants With Arrhythmias |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fahim Khorfan, MD | Ascension Health | Principal Investigator |
| Kimberly R Barber, PhD | Ascension Health | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Genesys Regional Medical Center | Grand Blanc | Michigan | 48439 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21960699 | Derived | Khorfan FM, Smith P, Watt S, Barber KR. Effects of nebulized bronchodilator therapy on heart rate and arrhythmias in critically ill adult patients. Chest. 2011 Dec;140(6):1466-1472. doi: 10.1378/chest.11-0525. Epub 2011 Sep 29. |
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Patients were excluded if they had a known allergy or sensitivity to study medications or if baseline heart rate was greater than 110 bpm. Treating physicians detremined the need for and frequency of treatment with bronchodilator therapy. All other medications were allowed.
Recruitment began initially August 21, 2007 at the medical center ICU.
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| ID | Title | Description |
|---|---|---|
| FG000 | Nebulized Albuterol 2.5mg | Patients were randomized to receive an initial dose of albuterol 2.5 mg alternating with levalbuterol 0.63 mg. |
| FG001 | Levalbuterol 1.25 | Patients received an initial dose of levalbuterol 1.25 mg alternating with albuterol 2.5 mg. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The number analyzed was determined by the power calculation and based on the number of participants randomized to treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Nebulized Albuterol 2.5mg | Patients were randomized to receive an initial dose of albuterol 2.5 mg alternating with levalbuterol 0.63 mg. |
| BG001 | Levalbuterol 1.25 | Patients received an initial dose of levalbuterol 1.25 mg alternating with albuterol 2.5 mg. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Heart Rate in Beats Per Minute | Average difference in Heart rate between pre and post breathing treatments | Average change in heart rate from baseline to final breathing treatment. | Posted | Mean | Standard Deviation | bpm | Five days | Breathing treatment episodes | Participants |
|
Within 5 days of treatment initiation and within 15 minutes of each individual treatment.
Cardiac arrhythmia
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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 | Nebulized Albuterol 2.5mg | Patients were randomized to receive an initial dose of albuterol 2.5 mg alternating with levalbuterol 0.63 mg. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ventricular tachycardia | Cardiac disorders | Systematic Assessment | Cardiac arrhythmia as documented by healthcare provider. |
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Potential limitations are its single-center site and that the design may not have adequately eliminated all carryover effects from the levalbuterol. However, the number of side effects without carryover would be even lower than we observed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Fahim Khorfan | Genesys Regional Medical Center | 810-606-7722 | kbarber@genesys.org |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D018805 | Sepsis |
| D012769 | Shock |
| D013610 | Tachycardia |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| D064412 | Levalbuterol |
| D009241 | Ipratropium |
| D000420 | Albuterol |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| Albuterol | Drug | Nebulized albuterol 2.5mg |
|
|
Documented new arrhythmia occurring during study.
| Five days |
| Not meet inclusion criteria |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
| Breathing treatment episodes |
|
|
|
| Secondary | Arrhythmias | Any new arrhythmia documented in the medical record that occurred between breathing treatments. | The percentage of arrhythmias among the number of breathing treatments. | Posted | Number | percent | 15 minutes after each treatment for average of 3 to 5 days |
|
|
|
|
| Secondary | Total Number of Participants With Arrhythmias | Documented new arrhythmia occurring during study. | Number of patients for whom arrhythmias occurred within 5 days after treatment initiation. | Posted | Number | participants | Five days |
|
|
|
|
| 2 |
| 58 |
| 0 |
| 58 |
| EG001 | Levalbuterol 1.25 | Patients received an initial dose of levalbuterol 1.25 mg alternating with albuterol 2.5 mg. | 3 | 31 | 0 | 31 |
|
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| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D000075224 | Cardiac Conduction System Disease |
| D000588 |
| Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D001286 | Atropine Derivatives |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
| D001533 | Belladonna Alkaloids |
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |