Pilot Study of Magnesium Infusions in Pediatric Asthma

Phase 2

Withdrawn

• Conditions: Asthma
• Interventions: Drug: Placebo; Drug: Magnesium Sulfate

• Registration Number: NCT01522040
• Lead Sponsor: University of Louisville

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

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.

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-01-24
• Study First Submitted QC: 2012-01-26
• Study First Posted: 2012-01-31
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-29
• Last Update Posted: 2017-03-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Placebo	Half the subjects will be randomized to receive a drip that does not have active drug (magnesium sulfate).
Magnesium	Magnesium Sulfate	Half the enrolled subjects will be randomized to receive active drug, a magnesium infusion.

Primary Outcome Measures

Name	Time	Method
Time to discharge	Duration of hospital stay, typically 3-5 days	The primary outcome for this study is elapsed time from emergency department (ED) presentation to readiness for PICU discharge.

Secondary Outcome Measures

Name	Time	Method
Beta receptor haplotype	Once on enrollment	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.

Trial Locations

Locations (1)

Kosair Children's Hospital; 🇺🇸 Louisville, Kentucky, United States