Pilot Study of Magnesium Infusions in Pediatric Asthma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by University of Louisville.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Keith Cross, University of Louisville
ClinicalTrials.gov Identifier:
NCT01522040
First received: January 24, 2012
Last updated: June 12, 2012
Last verified: June 2012

January 24, 2012
June 12, 2012
January 2012
July 2014   (final data collection date for primary outcome measure)
Time to discharge [ Time Frame: Duration of hospital stay, typically 3-5 days ] [ Designated as safety issue: No ]
The primary outcome for this study is elapsed time from emergency department (ED) presentation to readiness for PICU discharge.
Same as current
Complete list of historical versions of study NCT01522040 on ClinicalTrials.gov Archive Site
Beta receptor haplotype [ Time Frame: Once on enrollment ] [ Designated as safety issue: No ]
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.
Beta receptor haplotype [ Designated as safety issue: No ]
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.
Not Provided
Not Provided
 
Pilot Study of Magnesium Infusions in Pediatric Asthma
A Pilot Study of Magnesium Infusions (Drips) for Moderate-to-Severe Pediatric Asthma Exacerbations

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?

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Asthma
  • Drug: Magnesium Sulfate
    Continuous magnesium drip, titrated to effect until patient's symptoms improve
  • Drug: Placebo
    Simple saline drip, without active drug
  • Active Comparator: Magnesium
    Half the enrolled subjects will be randomized to receive active drug, a magnesium infusion.
    Intervention: Drug: Magnesium Sulfate
  • Placebo Comparator: Control
    Half the subjects will be randomized to receive a drip that does not have active drug (magnesium sulfate).
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
Not Provided
July 2014   (final data collection date for primary outcome measure)

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
Both
2 Years to 20 Years
No
Contact: Keith Cross, MD 5026892457 keith.cross@louisville.edu
Contact: Kendra Sikes 502-629-7212
United States
 
NCT01522040
11.0641
Yes
Keith Cross, University of Louisville
University of Louisville
Not Provided
Not Provided
University of Louisville
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP