Pilot Study of Magnesium Infusions in Pediatric Asthma
This study is currently recruiting participants.
Verified June 2012 by University of Louisville
Sponsor:
University of Louisville
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Asthma |
Drug: Magnesium Sulfate Drug: Placebo |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Pilot Study of Magnesium Infusions (Drips) for Moderate-to-Severe Pediatric Asthma Exacerbations |
Resource links provided by NLM:
Further study details as provided by University of Louisville:
Primary Outcome Measures:
- 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.
Secondary Outcome Measures:
- 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.
| Estimated Enrollment: | 20 |
| Study Start Date: | January 2012 |
| Estimated Primary Completion Date: | July 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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.
Eligibility| Ages Eligible for Study: | 2 Years to 20 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01522040
Contacts
| Contact: Keith Cross, MD | 5026892457 | keith.cross@louisville.edu |
| Contact: Kendra Sikes | 502-629-7212 |
Locations
| United States, Kentucky | |
| Kosair Children's Hospital | Recruiting |
| Louisville, Kentucky, United States, 40204 | |
| Contact: Keith 502-689-2457 keith.cross@louisville.edu | |
| Principal Investigator: Keith Cross, MD | |
Sponsors and Collaborators
University of Louisville
More Information
No publications provided
| Responsible Party: | Keith Cross, Assistant Professor of Pediatrics, University of Louisville |
| ClinicalTrials.gov Identifier: | NCT01522040 History of Changes |
| Other Study ID Numbers: | 11.0641 |
| Study First Received: | January 24, 2012 |
| Last Updated: | June 12, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Louisville:
|
Asthma Magnesium Adrenergic Receptor |
Additional relevant MeSH terms:
|
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Magnesium Sulfate Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs |
Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Anesthetics Central Nervous System Depressants Anti-Arrhythmia Agents Cardiovascular Agents Anticonvulsants Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Tocolytic Agents Reproductive Control Agents |
ClinicalTrials.gov processed this record on May 16, 2013