Pilot Study of Magnesium Infusions in Pediatric Asthma

University of Louisville (UOFL)

Status and phase: Withdrawn; Phase 3; Phase 2

Conditions: Asthma

Treatments: Drug: Magnesium Sulfate; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01522040

11.0641

Details and patient eligibility

About

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?

Full 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.

Sex: All

Ages: 2 to 20 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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0 participants in 2 patient groups, including a placebo group

Magnesium

Active Comparator group

Description:

Half the enrolled subjects will be randomized to receive active drug, a magnesium infusion.

Treatment:

Drug: Magnesium Sulfate

Control

Placebo Comparator group

Description:

Half the subjects will be randomized to receive a drip that does not have active drug (magnesium sulfate).

Treatment:

Drug: Placebo