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This is a prospective randomized pilot study that seeks to address the research question: In children with moderate-to-severe asthma, do intravenous magnesium infusions added to standard Pediatric intensive care unit (PICU)-level asthma care significantly decrease time from patient presentation until PICU discharge?
This study will be a double-blind, prospective randomized pilot study. Subjects will be randomized on a 1:1 basis to receive routine asthma care with or without a magnesium drip.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Magnesium | Active Comparator | Half the enrolled subjects will be randomized to receive active drug, a magnesium infusion. |
|
| Control | Placebo Comparator | Half the subjects will be randomized to receive a drip that does not have active drug (magnesium sulfate). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnesium Sulfate | Drug | Continuous magnesium drip, titrated to effect until patient's symptoms improve |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to discharge | The primary outcome for this study is elapsed time from emergency department (ED) presentation to readiness for PICU discharge. | Duration of hospital stay, typically 3-5 days |
| Measure | Description | Time Frame |
|---|---|---|
| Beta receptor haplotype | The subject's genetic haplotype for beta adrenergic receptor. It will be determined by blood test during their admission in the hospital and enrollment on the study protocol. | Once on enrollment |
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Inclusion Criteria:
Age 2 years 0 days up to 20 years 364 days
Clinical diagnosis of asthma including both of the following:
Planned PICU admission for moderate-to-severe asthma exacerbation persisting despite standard first-tier therapy (systemic corticosteroids and at least a one-hour treatment with nebulized albuterol/ipratroprium or equivalent) as evidenced by an asthma score of 7 or greater
IV access or equivalent
Ability to understand and give informed consent/assent in English
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Keith Cross, MD | University of Louisville | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kosair Children's Hospital | Louisville | Kentucky | 40204 | United States |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D008278 | Magnesium Sulfate |
| ID | Term |
|---|---|
| D017616 | Magnesium Compounds |
| D007287 | Inorganic Chemicals |
| D013431 | Sulfates |
| D013464 | Sulfuric Acids |
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| Placebo | Drug | Simple saline drip, without active drug |
|
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D013456 |
| Sulfur Acids |
| D013457 | Sulfur Compounds |