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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 19, 2014