Pilot Study of Magnesium Infusions in Pediatric Asthma

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01522040
• Other study ID #: 11.0641
• Status: Withdrawn
• Phase: Phase 2/Phase 3
• First received: January 24, 2012
• Last updated: March 29, 2017
• Start date: January 2012
• Est. completion date: October 2013

Study information

• Verified date: March 2017
• Source: University of Louisville
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 20 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Magnesium Sulfate
Continuous magnesium drip, titrated to effect until patient's symptoms improve
• Placebo
Simple saline drip, without active drug

Locations

Country	Name	City	State
United States	Kosair Children's Hospital	Louisville	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
University of Louisville

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Beta receptor haplotype	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