Pilot Study of Magnesium Infusions in Pediatric Asthma

March 29, 2017 updated by: Keith Cross, University of Louisville

A Pilot Study of Magnesium Infusions (Drips) for Moderate-to-Severe Pediatric Asthma Exacerbations

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?

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kentucky
      • Louisville, Kentucky, United States, 40204
        • Kosair Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 20 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to discharge
Time Frame: Duration of hospital stay, typically 3-5 days
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Beta receptor haplotype
Time Frame: Once on enrollment
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.
Once on enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Louisville

Investigators

  • Principal Investigator: Keith Cross, MD, University of Louisville

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

October 1, 2013

Study Registration Dates

First Submitted

January 24, 2012

First Submitted That Met QC Criteria

January 26, 2012

First Posted (Estimate)

January 31, 2012

Study Record Updates

Last Update Posted (Actual)

March 30, 2017

Last Update Submitted That Met QC Criteria

March 29, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11.0641

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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