Pilot Study of Magnesium Infusions in Pediatric Asthma

• Status: Withdrawn
• Trial end date: 2013-10-01
• Target enrollment: 0
• Participant gender: All

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 intensive care unit (PICU)-level asthma care significantly decrease time from patient presentation until PICU discharge?

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Louisville
• Treatments: Magnesium Sulfate

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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