Pilot Study of Magnesium Infusions in Pediatric Asthma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01522040
Recruitment Status : Withdrawn
First Posted : January 31, 2012
Last Update Posted : March 30, 2017
Information provided by (Responsible Party):
Keith Cross, 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?

Condition or disease Intervention/treatment Phase
Asthma Drug: Magnesium Sulfate Drug: Placebo Phase 2 Phase 3

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Pilot Study of Magnesium Infusions (Drips) for Moderate-to-Severe Pediatric Asthma Exacerbations
Study Start Date : January 2012
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Magnesium
Half the enrolled subjects will be randomized to receive active drug, a magnesium infusion.
Drug: Magnesium Sulfate
Continuous magnesium drip, titrated to effect until patient's symptoms improve
Placebo Comparator: Control
Half the subjects will be randomized to receive a drip that does not have active drug (magnesium sulfate).
Drug: Placebo
Simple saline drip, without active drug

Primary Outcome Measures :
  1. Time to discharge [ Time Frame: 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 :
  1. Beta receptor haplotype [ Time Frame: 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.

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Ages Eligible for Study:   2 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01522040

United States, Kentucky
Kosair Children's Hospital
Louisville, Kentucky, United States, 40204
Sponsors and Collaborators
University of Louisville
Principal Investigator: Keith Cross, MD University of Louisville

Responsible Party: Keith Cross, Assistant Professor of Pediatrics, University of Louisville Identifier: NCT01522040     History of Changes
Other Study ID Numbers: 11.0641
First Posted: January 31, 2012    Key Record Dates
Last Update Posted: March 30, 2017
Last Verified: March 2017

Keywords provided by Keith Cross, University of Louisville:
Adrenergic Receptor

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Magnesium Sulfate
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Depressants
Anti-Arrhythmia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Tocolytic Agents
Reproductive Control Agents