Status:
WITHDRAWN
Pilot Study of Magnesium Infusions in Pediatric Asthma
Lead Sponsor:
University of Louisville
Conditions:
Asthma
Eligibility:
All Genders
2-20 years
Phase:
PHASE2
PHASE3
Brief Summary
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 int...
Detailed Description
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.
Eligibility Criteria
Inclusion
- Age 2 years 0 days up to 20 years 364 days
- Clinical diagnosis of asthma including both of the following:
- Attending physician's primary working diagnosis is status asthmaticus
- Results of a modified International Study of Asthma and Allergies in Children (ISAAC) diagnostic questionnaire consistent with an asthma diagnosis
- 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
- Prior enrollment in this study
- Prior adverse reactions to magnesium
- Use of systemic corticosteroids or magnesium in preceding 2 weeks, or administered at a transferring facility more than 3 hours prior to enrollment
- Admission for inpatient asthma care in preceding 2 weeks
- Hemodynamic instability, impending respiratory failure or intubation
- Inability in children age 7 years or older to give assent due to a developmental delay or altered mental status
- Significant renal or cardiac disease
- Sickle cell anemia
- Significant, active non-asthma pulmonary disease
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01522040
Start Date
January 1 2012
End Date
October 1 2013
Last Update
March 30 2017
Active Locations (1)
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1
Kosair Children's Hospital
Louisville, Kentucky, United States, 40204