Back to resultsTwo Doses of the Intravenous Magnesium Sulfate Versus the Standard Single Dose ,With/ Without the Nebulized Budesonide For the Management of the Severe Asthma Exacerbation in the Emergency Room; A Randomized Controlled Trial.
Primary Purpose
Bronchial Asthma
Status
Unknown status
Phase
Phase 3
Locations
Qatar
Study Type
Interventional
Intervention
Hi-dose iv MgSO4
Nebulized budesonide
Std-dose iv MgSO4
Nebulized normal saline
Sponsored by
About this trial
This is an interventional treatment trial for Bronchial Asthma focused on measuring Bronchial Asthma, Intravenous magnesium sulfate, Inhaled budesonide
Eligibility Criteria
Inclusion Criteria:
- Children 2-14 years of age.
- Known to have bronchial asthma.
- Presenting in severe asthma exacerbation
- Asthma severity score 8 or higher according to PRAM asthma severity .
Exclusion Criteria:
- Prematurity <34 weeks of gestation.
- Critically ill children requiring immediate intubation or ICU admission.
- Transfers from other institutions.
- Adverse drug reaction or allergy to budesonide,salbutamol,ipratropium bromide, prednisone, prednisolone, methylprednisolone, or magnesium sulfate.
- History of neuromuscular disease, cardiac disease, renal disease, liver disease.
- Underlying chronic lung disease.
- Radiographic evidence of pneumonia or lung collapse .
- Hemodynamic instability.
- Instrumented airway or Tracheotomy.
- Colostomy or ileostomy.
- Malabsorption disorder.
- Known vitamin D deficiency.
- Receiving Milk of Magnesium for Constipation
- Chronic diarrhea (duration for 2 weeks)
- Diuretics use.
- Immunodeficiency.
Sites / Locations
- Hamad Medical CorporationRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Placebo Comparator
Active Comparator
Placebo Comparator
Arm Label
Hi-Mg + Bud
Hi-Mg + P
Std-Mg + Bud
St-Mg + P
Arm Description
Group one will receive a high,then standard dose of intravenous magnesium sulfate with blinded nebulized budesonide.
Group two will receive a high,then standard dose of intravenous magnesium sulfate with blinded nebulized normal saline.
Group three will receive a single standard dose of intravenous magnesium sulfate plus one dose of intravenous normal saline with blinded nebulized budesonide.
Group four will receive a single dose of intravenous magnesium sulfate plus one dose of intravenous normal saline with blinded nebulized normal saline
Outcomes
Primary Outcome Measures
Time to medical readiness for discharge.
Accelerated failure time analyses of each of the blinded interventions will use the entire population,as this is a 2x2 factorial study.We will use retrospective stratification & quantitative interaction analysis to determine if the magnesium or magnesium placebo intervention has a different effect in the budesonide or budesonide placebo group.
Secondary Outcome Measures
Overall length of the hospital stay (hours/days) .
The rate of admission to pediatric intensive care unit (%)
Comparison of clinical response in severity score (%)
Frequency of need for revisit to pediatric emergency center for same diagnosis(%)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02455687
Brief Title
Two Doses of the Intravenous Magnesium Sulfate Versus the Standard Single Dose ,With/ Without the Nebulized Budesonide For the Management of the Severe Asthma Exacerbation in the Emergency Room; A Randomized Controlled Trial.
Official Title
Two Doses of the Intravenous Magnesium Sulfate Versus the Standard Single Dose With/Without Nebulized Budesonide for the Emergency Management of the Severe Asthma. A Randomized Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 2015 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hamad Medical Corporation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Many studies have investigated the efficacy and safety of Intravenous magnesium sulfate and inhaled steroids in addition to the standard treatment for patients with severe asthma attacks.
In this 2x2 factorial design blinded randomized study, no interaction of hypothesized treatments is expected.Investigators hypothesize that two doses of intravenous magnesium sulfate,a high dose followed by a (lower) standard dose, will shorten the time to medical readiness for discharge compared to a single standard dose followed by placebo.The second hypothesis is that nebulized inhaled budesonide will be superior to placebo.
Detailed Description
Patient with a severe asthma attack will be admitted to the observation area in the Pediatric Emergency Center and assessed for eligibility for the study by the attending physician, based upon our study inclusion/exclusion criteria.
Eligible patients will be enrolled after obtaining written consent from the parents. Patients will receive routine treatment for a severe asthma attack, such as inhaled bronchodilators, plus intravenous steroids and supplementary oxygen if needed. Standard blood work and chest X-Ray will be obtained and bronchial asthma severity score will be measured at baseline before starting treatment,and then at 4,8,12,24,36,48 hr and thereafter. The medical team as well as parents and patient will be blinded to the medications delivered. The patient will be randomized into one of the four study groups and adverse effects of the medications in each group will be monitored and documented carefully.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchial Asthma
Keywords
Bronchial Asthma, Intravenous magnesium sulfate, Inhaled budesonide
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
240 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Hi-Mg + Bud
Arm Type
Active Comparator
Arm Description
Group one will receive a high,then standard dose of intravenous magnesium sulfate with blinded nebulized budesonide.
Arm Title
Hi-Mg + P
Arm Type
Placebo Comparator
Arm Description
Group two will receive a high,then standard dose of intravenous magnesium sulfate with blinded nebulized normal saline.
Arm Title
Std-Mg + Bud
Arm Type
Active Comparator
Arm Description
Group three will receive a single standard dose of intravenous magnesium sulfate plus one dose of intravenous normal saline with blinded nebulized budesonide.
Arm Title
St-Mg + P
Arm Type
Placebo Comparator
Arm Description
Group four will receive a single dose of intravenous magnesium sulfate plus one dose of intravenous normal saline with blinded nebulized normal saline
Intervention Type
Drug
Intervention Name(s)
Hi-dose iv MgSO4
Intervention Type
Drug
Intervention Name(s)
Nebulized budesonide
Other Intervention Name(s)
Pulmicort
Intervention Type
Drug
Intervention Name(s)
Std-dose iv MgSO4
Intervention Type
Drug
Intervention Name(s)
Nebulized normal saline
Primary Outcome Measure Information:
Title
Time to medical readiness for discharge.
Description
Accelerated failure time analyses of each of the blinded interventions will use the entire population,as this is a 2x2 factorial study.We will use retrospective stratification & quantitative interaction analysis to determine if the magnesium or magnesium placebo intervention has a different effect in the budesonide or budesonide placebo group.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Overall length of the hospital stay (hours/days) .
Time Frame
3 years
Title
The rate of admission to pediatric intensive care unit (%)
Time Frame
3 years
Title
Comparison of clinical response in severity score (%)
Time Frame
3 years
Title
Frequency of need for revisit to pediatric emergency center for same diagnosis(%)
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Children 2-14 years of age.
Known to have bronchial asthma.
Presenting in severe asthma exacerbation
Asthma severity score 8 or higher according to PRAM asthma severity .
Exclusion Criteria:
Prematurity <34 weeks of gestation.
Critically ill children requiring immediate intubation or ICU admission.
Transfers from other institutions.
Adverse drug reaction or allergy to budesonide,salbutamol,ipratropium bromide, prednisone, prednisolone, methylprednisolone, or magnesium sulfate.
History of neuromuscular disease, cardiac disease, renal disease, liver disease.
Underlying chronic lung disease.
Radiographic evidence of pneumonia or lung collapse .
Hemodynamic instability.
Instrumented airway or Tracheotomy.
Colostomy or ileostomy.
Malabsorption disorder.
Known vitamin D deficiency.
Receiving Milk of Magnesium for Constipation
Chronic diarrhea (duration for 2 weeks)
Diuretics use.
Immunodeficiency.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Khalid Alansari, MD
Phone
+974-55336166
Email
kalansari@hamad.qa
First Name & Middle Initial & Last Name or Official Title & Degree
Faten Abumusa, MD
Phone
+974-55312922
Email
fmoussa@hamad.qa
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Khalid Alansari, MD
Organizational Affiliation
Sidra Medicine
Official's Role
Study Director
Facility Information:
Facility Name
Hamad Medical Corporation
City
Doha
ZIP/Postal Code
3050
Country
Qatar
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Two Doses of the Intravenous Magnesium Sulfate Versus the Standard Single Dose ,With/ Without the Nebulized Budesonide For the Management of the Severe Asthma Exacerbation in the Emergency Room; A Randomized Controlled Trial.
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