COPD, Sepsis, Shock
Conditions
Keywords
Tachycardia, tachyarrhythmias, bronchodilator therapy, Critically ill patients
Brief summary
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.
Detailed description
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.
Interventions
DRUGLevalbuterol
inhaled Levalbuterol 0.625 mg inhaled Levalbuterol 2.5 mg
DRUGAlbuterol
Nebulized albuterol 2.5mg
Sponsors
Ascension Health
Fahim Khorfan, MD
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults who required inhaled bronchodilator therapy in the form of short acting beta adrenergic receptor agonist and short acting anti-cholinergic treatment every 4-6 hours for respiratory functions
Exclusion criteria
* Known allergy or sensitivity to study medications * Baseline heart rate was greater than 110 beats per minute
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Heart Rate in Beats Per Minute | Five days | Average difference in Heart rate between pre and post breathing treatments |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Arrhythmias | 15 minutes after each treatment for average of 3 to 5 days | Any new arrhythmia documented in the medical record that occurred between breathing treatments. |
| Total Number of Participants With Arrhythmias | Five days | Documented new arrhythmia occurring during study. |
Countries
United States
Participant flow
Recruitment details
Recruitment began initially August 21, 2007 at the medical center ICU.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Nebulized Albuterol 2.5mg Patients were randomized to receive an initial dose of albuterol 2.5 mg alternating with levalbuterol 0.63 mg. | 58 |
| Levalbuterol 1.25 Patients received an initial dose of levalbuterol 1.25 mg alternating with albuterol 2.5 mg. | 31 |
| Total | 89 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Not meet inclusion criteria | 6 | 4 |
| Overall Study | Physician Decision | 3 | 1 |
| Overall Study | Withdrawal by Subject | 3 | 2 |
Baseline characteristics
| Characteristic | Levalbuterol 1.25 | Nebulized Albuterol 2.5mg | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 22 Participants | 40 Participants | 62 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants | 18 Participants | 27 Participants |
| Age, Continuous | 67.5 years STANDARD_DEVIATION 13.7 | 67.3 years STANDARD_DEVIATION 13.1 | 67.3 years STANDARD_DEVIATION 13.4 |
| Region of Enrollment United States | 31 participants | 58 participants | 89 participants |
| Sex: Female, Male Female | 12 Participants | 31 Participants | 43 Participants |
| Sex: Female, Male Male | 19 Participants | 27 Participants | 46 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 58 | 0 / 31 |
| serious Total, serious adverse events | 2 / 58 | 3 / 31 |
Outcome results
Primary
Heart Rate in Beats Per Minute
Average difference in Heart rate between pre and post breathing treatments
Time frame: Five days
Population: Average change in heart rate from baseline to final breathing treatment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nebulized Albuterol 2.5mg | Heart Rate in Beats Per Minute | -0.16 bpm | Standard Deviation 5.1 |
| Levalbuterol 1.25 | Heart Rate in Beats Per Minute | 1.40 bpm | Standard Deviation 5.4 |
Comparison: Null Hypothesis: No difference between groups in heart rate changes from baseline following treatment. Sample size calculation determined a need for at least 400 breathing treatments among 65 patients.p-value: 0.01Mixed Models Analysis
Secondary
Arrhythmias
Any new arrhythmia documented in the medical record that occurred between breathing treatments.
Time frame: 15 minutes after each treatment for average of 3 to 5 days
Population: The percentage of arrhythmias among the number of breathing treatments.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nebulized Albuterol 2.5mg | Arrhythmias | 0.33 percent |
| Levalbuterol 1.25 | Arrhythmias | 1.3 percent |
Comparison: Null hypothesis: no difference in incidence of arrhythmias between groups within the total number of breathing treatments.p-value: 0.05Chi-squared
Secondary
Total Number of Participants With Arrhythmias
Documented new arrhythmia occurring during study.
Time frame: Five days
Population: Number of patients for whom arrhythmias occurred within 5 days after treatment initiation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nebulized Albuterol 2.5mg | Total Number of Participants With Arrhythmias | 2 participants |
| Levalbuterol 1.25 | Total Number of Participants With Arrhythmias | 3 participants |
Comparison: To report on the number of events.p-value: 0descriptive