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Nebulized Magnesium Sulfate in Children With Moderate to Severe Asthma Exacerbation

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by University of Texas Southwestern Medical Center
Sponsor:
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT01515995
First received: January 11, 2012
Last updated: January 3, 2014
Last verified: January 2014
  Purpose

The purpose of this study is to evaluate the effectiveness of nebulized magnesium sulfate as a vehicle for albuterol in children with moderate to severe asthma exacerbation.


Condition Intervention Phase
Asthma
Drug: Nebulized magnesium sulfate
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Nebulized Magnesium Sulfate Versus Normal Saline as a Vehicle for Albuterol in Children With Moderate to Severe Asthma Exacerbation: a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • Change in forced expiratory volume in one second (FEV1) [ Time Frame: Baseline and one hour after treatment ] [ Designated as safety issue: Yes ]
    Change in forced expiratory volume in one second (FEV1) as measured by bedside spirometry before and after study intervention.


Secondary Outcome Measures:
  • Change in Pediatric Asthma Severity Score (PASS) [ Time Frame: Baseline and one hour after treatment ] [ Designated as safety issue: Yes ]
    The change in Pediatric Asthma Severity Score (PASS) before and after administration of the study drug will be recorded

  • Patients' Disposition [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]

    Patients' disposition will be monitored:

    • home
    • inpatient admission on intermittent albuterol
    • inpatient admission on continuous albuterol

  • Length of Emergency Department (ED) stay [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
    The length of stay in the Emergency Department (ED) will be monitored

  • Return rates to the Emergency Department [ Time Frame: 72 hours ] [ Designated as safety issue: Yes ]
    Enrolled patients who return to the Emergency Department within 72 hours will be monitored and followed


Estimated Enrollment: 90
Study Start Date: January 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Magnesium sulfate group
15 mg albuterol in 22 ml of magnesium sulfate solution (880 mg) via nebulizer over one hour
Drug: Nebulized magnesium sulfate

15 mg albuterol in 22 ml of magnesium sulfate solution (880 mg) via nebulizer over one hour

Versus

15 mg albuterol in 22 ml of normal saline via nebulizer over one hour

Other Name: Inhaled magnesium sulfate
Active Comparator: Normal Saline group
15 mg albuterol in 22 ml of normal saline solution via nebulizer over one hour
Drug: Nebulized magnesium sulfate

15 mg albuterol in 22 ml of magnesium sulfate solution (880 mg) via nebulizer over one hour

Versus

15 mg albuterol in 22 ml of normal saline via nebulizer over one hour

Other Name: Inhaled magnesium sulfate

Detailed Description:

Patients presenting to the Emergency Department for acute asthma exacerbation will receive standard care of up to three doses of albuterol and ipratropium bromide plus oral steroid medication. Those seven years of age and older who require further treatment will be screened for eligibility. Eligibility screening will comprise measurement of forced expiratory volume in one second (FEV1) with a bedside spirometer by a respiratory therapist. Children under the age of seven are generally unable to complete spirometry maneuvers and will thus be excluded. The Pediatric Asthma Severity Score (PASS) will also be noted by a respiratory therapist. Patients able to complete spirometry testing and with an FEV1 less than 70% of predicted (the definition of moderate asthma exacerbation) will be enrolled. Enrolled patients will be randomized to receive either Children's Medical Center standard care of 15 mg albuterol diluted in 22 ml of normal saline or the study intervention of 15 mg of albuterol diluted in 22 ml of magnesium sulfate solution. This solution will be prepared at the time of use by a pharmacist in the Emergency Department and will consist of 22 ml of a commercially available 40 mg/ml magnesium sulfate solution (880 mg). The nebulizer treatment will be given over approximately one hour via a large volume nebulizer at 25 ml/hr. Physicians, nurses, and respiratory therapists will be blinded to the diluent used. Vital signs will be noted at baseline. Heart rate, heart rhythm, respiratory rate, and pulse oximetry will be monitored continuously while blood pressure will be measured at baseline and every 15 minutes during study medication administration. The study physician, treating physician, and/or bedside nurse will monitor these values for any clinically significant changes. At the end of the 15 mg albuterol treatment FEV1 and PASS will again be noted. Any further treatments needed, as determined by the treating physician, will be given following Children's Medical Center standard of care. At the discretion of the treating physician intravenous magnesium sulfate may be used post study intervention. The dose used for study participants will be the Children's Medical Center standard dose of 75 mg/kg (max 3 g) minus 880 mg to avoid the risk of magnesium sulfate overdose. Further treatments and patient disposition will be observed by study personnel and noted. Bounce-back rates will be collected by review of enrolled patients' medical record.

  Eligibility

Ages Eligible for Study:   7 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients age ≥ seven years
  • Previous diagnosis of asthma or previous episode of wheezing treated with beta-agonist medication
  • Able to complete bedside spirometry
  • FEV1 < 70% predicted

Exclusion Criteria:

  • Known allergy to magnesium sulfate
  • Known contra-indication to albuterol
  • Respiratory distress occurring as a result of bedside spirometry
  • History of neuromuscular disease, cardiac disease, renal disease, or underlying chronic lung disease
  • Pregnancy
  • Use of oral steroid medication within 72 hours of presentation
  • Radiographic evidence of pneumonia at presentation
  • Intubation during the current encounter prior to study enrollment
  • Administration of intravenous magnesium sulfate prior to study enrollment
  • Prior participation in this study
  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: NCT01515995

Contacts
Contact: Mohamed Badawy, MD 214-456-0195 Mohamed.Badawy@utsouthwestern.edu
Contact: David Rodriguez, MD David.Rodriguez@utsouthwestern.edu

Locations
United States, Texas
Children's Medical Center Dallas Recruiting
Dallas, Texas, United States, 75390
Principal Investigator: Mohamed Badawy, MD         
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
Study Director: Mohamed Badawy, MD UT Southwestern Medical Center
  More Information

No publications provided

Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT01515995     History of Changes
Other Study ID Numbers: ( STU 072011-043)
Study First Received: January 11, 2012
Last Updated: January 3, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Texas Southwestern Medical Center:
Magnesium sulfate
Childhood asthma
Emergency department

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases
Albuterol
Magnesium Sulfate
Adrenergic Agents
Adrenergic Agonists
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Analgesics
Anesthetics
Anti-Arrhythmia Agents
Anti-Asthmatic Agents
Anticonvulsants
Autonomic Agents
Bronchodilator Agents
Calcium Channel Blockers
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on November 20, 2014