Pilot Study of Magnesium Infusions in Pediatric Asthma

NCT01522040 | Withdrawn Phase 2 DMC

• 1 other identifier: 11.0641
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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?

Conditions

Asthma

Keywords

Asthma; Magnesium; Adrenergic Receptor

Outcome Measures

Primary Outcomes (1)

• Time to discharge

  The primary outcome for this study is elapsed time from emergency department (ED) presentation to readiness for PICU discharge.

  Duration of hospital stay, typically 3-5 days

Secondary Outcomes (1)

• Beta receptor haplotype

  Once on enrollment

Study Arms (2)

Magnesium

ACTIVE COMPARATOR

Half the enrolled subjects will be randomized to receive active drug, a magnesium infusion.

Drug: Magnesium Sulfate

Control

PLACEBO COMPARATOR

Half the subjects will be randomized to receive a drip that does not have active drug (magnesium sulfate).

Drug: Placebo

Interventions

Magnesium Sulfate DRUG

Continuous magnesium drip, titrated to effect until patient's symptoms improve

Magnesium

Placebo DRUG

Simple saline drip, without active drug

Control

Eligibility Criteria

• Age: 2 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Louisville: lead

Study Sites (1)

Kosair Children's Hospital

Louisville, Kentucky, 40204, United States

Location

MeSH Terms

Conditions

Asthma

Interventions

Magnesium Sulfate

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Keith Cross, MD

  University of Louisville

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics

Study Record Dates

• First Submitted: January 24, 2012
• First Posted: January 31, 2012
• Study Start: January 1, 2012
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: March 30, 2017

Record last verified: 2017-03

Locations

US (1)