Back to resultsPilot Study of Magnesium Infusions in Pediatric Asthma
Primary Purpose
Asthma
Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Magnesium Sulfate
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Asthma focused on measuring Asthma, Magnesium, Adrenergic Receptor
Eligibility 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
Sites / Locations
- Kosair Children's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Magnesium
Control
Arm Description
Half the enrolled subjects will be randomized to receive active drug, a magnesium infusion.
Half the subjects will be randomized to receive a drip that does not have active drug (magnesium sulfate).
Outcomes
Primary Outcome Measures
Time to discharge
The primary outcome for this study is elapsed time from emergency department (ED) presentation to readiness for PICU discharge.
Secondary Outcome Measures
Beta receptor haplotype
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.
Full Information
NCT ID
NCT01522040
First Posted
January 24, 2012
Last Updated
March 29, 2017
Sponsor
University of Louisville
1. Study Identification
Unique Protocol Identification Number
NCT01522040
Brief Title
Pilot Study of Magnesium Infusions in Pediatric Asthma
Official Title
A Pilot Study of Magnesium Infusions (Drips) for Moderate-to-Severe Pediatric Asthma Exacerbations
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Withdrawn
Study Start Date
January 2012 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Louisville
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Asthma, Magnesium, Adrenergic Receptor
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Magnesium
Arm Type
Active Comparator
Arm Description
Half the enrolled subjects will be randomized to receive active drug, a magnesium infusion.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Half the subjects will be randomized to receive a drip that does not have active drug (magnesium sulfate).
Intervention Type
Drug
Intervention Name(s)
Magnesium Sulfate
Intervention Description
Continuous magnesium drip, titrated to effect until patient's symptoms improve
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Simple saline drip, without active drug
Primary Outcome Measure Information:
Title
Time to discharge
Description
The primary outcome for this study is elapsed time from emergency department (ED) presentation to readiness for PICU discharge.
Time Frame
Duration of hospital stay, typically 3-5 days
Secondary Outcome Measure Information:
Title
Beta receptor haplotype
Description
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.
Time Frame
Once on enrollment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Keith Cross, MD
Organizational Affiliation
University of Louisville
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kosair Children's Hospital
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40204
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Pilot Study of Magnesium Infusions in Pediatric Asthma
We'll reach out to this number within 24 hrs