Pilot Study of Magnesium Infusions in Pediatric Asthma

NCT ID: NCT01522040

Last Updated: 2017-03-30

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2/PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2013-10-31

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.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Magnesium

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

Group Type: ACTIVE_COMPARATOR

Magnesium Sulfate

Intervention Type: DRUG

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

Control

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Simple saline drip, without active drug

Interventions

Magnesium Sulfate

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

Intervention Type: DRUG

Placebo

Simple saline drip, without active drug

Intervention Type: DRUG

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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Louisville

OTHER

Sponsor Role: lead

Responsible Party

Keith Cross

Assistant Professor of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Keith Cross, MD

Role: PRINCIPAL_INVESTIGATOR

University of Louisville

Locations

Kosair Children's Hospital

Louisville, Kentucky, United States

Countries

United States

Other Identifiers

11.0641

Identifier Type: -

Identifier Source: org_study_id