ID

36848

Description

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.; ODM derived from: https://clinicaltrials.gov/show/NCT02455687 Many studies have worked on the efficacy and safety of Intravenous magnesium sulfate and inhaled steroids beside the standard treatment for patients with severe asthma attacks. Investigators hypothesize that, two doses if intravenous magnesium sulfate with or without inhaled budesonide, would make the stay at the Pediatric emergency center (PEC) lesser,and decrease the need of being admitted to Pediatric Intensive Care Unit (PICU) for children with severe asthma attacks,compared to single dose of magnesium sulfate with or without inhaled budesonide.

Link

https://clinicaltrials.gov/show/NCT02455687

Keywords

Versions (1)
  1. 6/15/19 6/15/19 -
Copyright Holder

Hamad Medical Corporation

Uploaded on

June 15, 2019

DOI

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License

Creative Commons BY-NC 3.0
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Magnesium Sulfate in Bronchial Asthma NCT02455687

English

Eligibility Criteria

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Criteria
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
Is the participant a child of 2-14 years of age?
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
Is the participant known to have bronchial asthma?
Description

Bronchial asthma

Data type

boolean

Alias
UMLS CUI [1,1]
C0004096
UMLS CUI [1,2]
C0205309
Is the patient presenting in severe asthma exacerbation?
Description

Asthma exacerbation

Data type

boolean

Alias
UMLS CUI [1,1]
C0349790
UMLS CUI [1,2]
C0205082
Does the particapant have a asthma severity score 8 or higher according to pram asthma severity?
Description

PRAM asthma score

Data type

boolean

Alias
UMLS CUI [1,1]
C0581122
UMLS CUI [1,2]
C0449820
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
Does the participant have prematurity <34 weeks of gestation?
Description

Prematurity

Data type

boolean

Alias
UMLS CUI [1]
C0021294
Is the participant a critically ill child requiring immediate intubation or icu admission?
Description

Critically ill

Data type

boolean

Alias
UMLS CUI [1,1]
C0175989
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0021925
UMLS CUI [2,1]
C0175989
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0583239
Does the participant have transfers from other institutions?
Description

Transfer from other institutions

Data type

boolean

Alias
UMLS CUI [1,1]
C1546432
UMLS CUI [1,2]
C0205394
Does the participant have an adverse drug reaction or allergy to budesonide, salbutamol, ipratropium bromide, prednisone, prednisolone, methylprednisolone, or magnesium sulfate?
Description

Adverse drug reaction

Data type

boolean

Alias
UMLS CUI [1,1]
C0041755
UMLS CUI [1,2]
C0054201
UMLS CUI [2]
C0414042
UMLS CUI [3,1]
C0041755
UMLS CUI [3,2]
C0700580
UMLS CUI [4,1]
C0041755
UMLS CUI [4,2]
C0032952
UMLS CUI [5,1]
C0041755
UMLS CUI [5,2]
C0032950
UMLS CUI [6,1]
C0041755
UMLS CUI [6,2]
C0025815
UMLS CUI [7,1]
C0020517
UMLS CUI [7,2]
C0054201
UMLS CUI [8,1]
C0020517
UMLS CUI [8,2]
C0700580
UMLS CUI [9,1]
C0020517
UMLS CUI [9,2]
C0032952
UMLS CUI [10,1]
C0020517
UMLS CUI [10,2]
C0032950
UMLS CUI [11,1]
C0020517
UMLS CUI [11,2]
C0025815
UMLS CUI [12,1]
C0020517
UMLS CUI [12,2]
C0024480
Does the participant have a history of neuromuscular disease, cardiac disease, renal disease, liver disease?
Description

Neuromuscular, cardiac, renal or liver disease

Data type

boolean

Alias
UMLS CUI [1]
C0027868
UMLS CUI [2]
C0018799
UMLS CUI [3]
C0022658
UMLS CUI [4]
C0023895
Does the participant have an underlying chronic lung disease.
Description

Chronic lung disease

Data type

boolean

Alias
UMLS CUI [1]
C0746102
Does the participant have radiographic evidence of pneumonia or lung collapse?
Description

Pneumonia or lung collapse

Data type

boolean

Alias
UMLS CUI [1,1]
C1711337
UMLS CUI [1,2]
C0032285
UMLS CUI [2,1]
C1711337
UMLS CUI [2,2]
C0004144
Does the participant have hemodynamic instability?
Description

Hemodynamic instability

Data type

boolean

Alias
UMLS CUI [1]
C0948268
Does the participant have an instrumented airway or tracheotomy.
Description

Instrumented airway or tracheotomy

Data type

boolean

Alias
UMLS CUI [1,1]
C0040590
UMLS CUI [1,2]
C0472567
Does the participant have colostomy or ileostomy.
Description

Colostomy or ileostomy

Data type

boolean

Alias
UMLS CUI [1]
C0009410
UMLS CUI [2]
C0020883
Does the participant have a malabsorption disorder?
Description

Malabsorption disorder

Data type

boolean

Alias
UMLS CUI [1]
C0024523
Does the participant have a known vitamin D deficiency?
Description

Vitamin D deficiency

Data type

boolean

Alias
UMLS CUI [1,1]
C0205309
UMLS CUI [1,2]
C0042870
Is the participant receiving milk of magnesium for constipation
Description

Milk of magnesium for constipation

Data type

boolean

Alias
UMLS CUI [1,1]
C0026131
UMLS CUI [1,2]
C0024467
UMLS CUI [1,3]
C0009806
Does the participant have chronic diarrhea (duration for 2 weeks)?
Description

Chronic diarrhea

Data type

boolean

Alias
UMLS CUI [1]
C0401151
Does the participant use diuretics?
Description

Diuretics

Data type

boolean

Alias
UMLS CUI [1]
C0012798
Does the participant have immunodeficiency?
Description

Immunodeficiency

Data type

boolean

Alias
UMLS CUI [1]
C3829792
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Similar models

Eligibility Criteria

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Criteria
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
Is the participant a child of 2-14 years of age?
boolean
C0001779 (UMLS CUI [1])
Bronchial asthma
Item
Is the participant known to have bronchial asthma?
boolean
C0004096 (UMLS CUI [1,1])
C0205309 (UMLS CUI [1,2])
Asthma exacerbation
Item
Is the patient presenting in severe asthma exacerbation?
boolean
C0349790 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
PRAM asthma score
Item
Does the particapant have a asthma severity score 8 or higher according to pram asthma severity?
boolean
C0581122 (UMLS CUI [1,1])
C0449820 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Prematurity
Item
Does the participant have prematurity <34 weeks of gestation?
boolean
C0021294 (UMLS CUI [1])
Critically ill
Item
Is the participant a critically ill child requiring immediate intubation or icu admission?
boolean
C0175989 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0021925 (UMLS CUI [1,3])
C0175989 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0583239 (UMLS CUI [2,3])
Transfer from other institutions
Item
Does the participant have transfers from other institutions?
boolean
C1546432 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Adverse drug reaction
Item
Does the participant have an adverse drug reaction or allergy to budesonide, salbutamol, ipratropium bromide, prednisone, prednisolone, methylprednisolone, or magnesium sulfate?
boolean
C0041755 (UMLS CUI [1,1])
C0054201 (UMLS CUI [1,2])
C0414042 (UMLS CUI [2])
C0041755 (UMLS CUI [3,1])
C0700580 (UMLS CUI [3,2])
C0041755 (UMLS CUI [4,1])
C0032952 (UMLS CUI [4,2])
C0041755 (UMLS CUI [5,1])
C0032950 (UMLS CUI [5,2])
C0041755 (UMLS CUI [6,1])
C0025815 (UMLS CUI [6,2])
C0020517 (UMLS CUI [7,1])
C0054201 (UMLS CUI [7,2])
C0020517 (UMLS CUI [8,1])
C0700580 (UMLS CUI [8,2])
C0020517 (UMLS CUI [9,1])
C0032952 (UMLS CUI [9,2])
C0020517 (UMLS CUI [10,1])
C0032950 (UMLS CUI [10,2])
C0020517 (UMLS CUI [11,1])
C0025815 (UMLS CUI [11,2])
C0020517 (UMLS CUI [12,1])
C0024480 (UMLS CUI [12,2])
Neuromuscular, cardiac, renal or liver disease
Item
Does the participant have a history of neuromuscular disease, cardiac disease, renal disease, liver disease?
boolean
C0027868 (UMLS CUI [1])
C0018799 (UMLS CUI [2])
C0022658 (UMLS CUI [3])
C0023895 (UMLS CUI [4])
Chronic lung disease
Item
Does the participant have an underlying chronic lung disease.
boolean
C0746102 (UMLS CUI [1])
Pneumonia or lung collapse
Item
Does the participant have radiographic evidence of pneumonia or lung collapse?
boolean
C1711337 (UMLS CUI [1,1])
C0032285 (UMLS CUI [1,2])
C1711337 (UMLS CUI [2,1])
C0004144 (UMLS CUI [2,2])
Hemodynamic instability
Item
Does the participant have hemodynamic instability?
boolean
C0948268 (UMLS CUI [1])
Instrumented airway or tracheotomy
Item
Does the participant have an instrumented airway or tracheotomy.
boolean
C0040590 (UMLS CUI [1,1])
C0472567 (UMLS CUI [1,2])
Colostomy or ileostomy
Item
Does the participant have colostomy or ileostomy.
boolean
C0009410 (UMLS CUI [1])
C0020883 (UMLS CUI [2])
Malabsorption disorder
Item
Does the participant have a malabsorption disorder?
boolean
C0024523 (UMLS CUI [1])
Vitamin D deficiency
Item
Does the participant have a known vitamin D deficiency?
boolean
C0205309 (UMLS CUI [1,1])
C0042870 (UMLS CUI [1,2])
Milk of magnesium for constipation
Item
Is the participant receiving milk of magnesium for constipation
boolean
C0026131 (UMLS CUI [1,1])
C0024467 (UMLS CUI [1,2])
C0009806 (UMLS CUI [1,3])
Chronic diarrhea
Item
Does the participant have chronic diarrhea (duration for 2 weeks)?
boolean
C0401151 (UMLS CUI [1])
Diuretics
Item
Does the participant use diuretics?
boolean
C0012798 (UMLS CUI [1])
Immunodeficiency
Item
Does the participant have immunodeficiency?
boolean
C3829792 (UMLS CUI [1])
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