Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Intravenous Magnesium for Sickle Cell Vasoocclusive Crisis (MAGiC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01197417
Recruitment Status : Completed
First Posted : September 9, 2010
Results First Posted : September 7, 2015
Last Update Posted : January 27, 2016
Sponsor:
Collaborator:
Pediatric Emergency Care Applied Research Network
Information provided by (Responsible Party):
Medical College of Wisconsin

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Sickle Cell Disease
Interventions Drug: Intravenous Magnesium Sulfate
Drug: Normal Saline Placebo
Enrollment 208
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Magnesium Group Placebo Group
Hide Arm/Group Description

Intravenous Magnesium Sulfate

Intravenous Magnesium Sulfate: 40 mg/kg (max 2.4 grams), infused at a concentration of 40 mg/ml (1 ml/kg, max 60 ml), every 8 hours for a total of 6 doses

Normal Saline placebo

Normal Saline Placebo: (1 ml/kg, max 60 ml), administered every 8 hours for a total of 6 doses

Period Title: Overall Study
Started 104 104
Received Study Drug 101 103
Completed 96 86
Not Completed 8 18
Reason Not Completed
Physician Decision             3             2
Withdrawal by Subject             2             4
Site miscommunication             0             1
Subject transferred to intensive care             0             1
Not consented in time to receive drug             0             1
Hypotension             1             2
Found to be ineligible             2             5
No 25-hour magnesium level             0             2
Arm/Group Title Magnesium Group Placebo Group Total
Hide Arm/Group Description

Intravenous Magnesium Sulfate

Intravenous Magnesium Sulfate: 40 mg/kg (max 2.4 grams), infused at a concentration of 40 mg/ml (1 ml/kg, max 60 ml), every 8 hours for a total of 6 doses

Normal Saline placebo

Normal Saline Placebo: (1 ml/kg, max 60 ml), administered every 8 hours for a total of 6 doses

Total of all reporting groups
Overall Number of Baseline Participants 104 104 208
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 104 participants 104 participants 208 participants
<=18 years
93
  89.4%
88
  84.6%
181
  87.0%
Between 18 and 65 years
11
  10.6%
16
  15.4%
27
  13.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 104 participants 104 participants 208 participants
13.4  (4.5) 13.8  (4.8) 13.6  (4.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 104 participants 104 participants 208 participants
Female
51
  49.0%
57
  54.8%
108
  51.9%
Male
53
  51.0%
47
  45.2%
100
  48.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 104 participants 104 participants 208 participants
Hispanic or Latino
3
   2.9%
5
   4.8%
8
   3.8%
Not Hispanic or Latino
96
  92.3%
94
  90.4%
190
  91.3%
Unknown or Not Reported
5
   4.8%
5
   4.8%
10
   4.8%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 104 participants 104 participants 208 participants
American Indian or Alaska Native 0 0 0
Asian 0 0 0
Native Hawaiian or Pacific Islander 0 0 0
Black or African American 99 94 193
White 0 0 0
More than one race 2 3 5
Unknown or not reported 3 4 7
Other 0 3 3
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 104 participants 104 participants 208 participants
104 104 208
1.Primary Outcome
Title Hospital Length of Stay (Hours)
Hide Description [Not Specified]
Time Frame From the time of the start of first study med infusion until hospital discharge or 12 hours after the last IV opioid, whichever occurs first, up to 10 days post enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug and who did not withdraw from data collection prior to outcome
Arm/Group Title Magnesium Group Placebo Group
Hide Arm/Group Description:

Intravenous Magnesium Sulfate

Intravenous Magnesium Sulfate: 40 mg/kg (max 2.4 grams), infused at a concentration of 40 mg/ml (1 ml/kg, max 60 ml), every 8 hours for a total of 6 doses

Normal Saline placebo

Normal Saline Placebo: (1 ml/kg, max 60 ml), administered every 8 hours for a total of 6 doses

Overall Number of Participants Analyzed 100 102
Median (Inter-Quartile Range)
Unit of Measure: hours
56
(27 to 109)
47
(24 to 99)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Magnesium Group, Placebo Group
Comments Null hypothesis of equal distributions of primary length of stay between treatment arms within all randomization strata
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.24
Comments [Not Specified]
Method Van Elteren test
Comments Randomization strata were defined by enrollment site, age group and hydroxyurea use within the last three months prior to enrollment
2.Secondary Outcome
Title Number of Morphine Equivalents Per Kilogram of Body Weight Used During Hospitalization
Hide Description [Not Specified]
Time Frame Total morphine equivalents used during the hospitalization will be recorded on the day of discharge, up to 10 days post enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug and who did not withdraw from data collection prior to either hospital discharge or 12 hours after last intravenous opioid.
Arm/Group Title Magnesium Group Placebo Group
Hide Arm/Group Description:

Intravenous Magnesium Sulfate

Intravenous Magnesium Sulfate: 40 mg/kg (max 2.4 grams), infused at a concentration of 40 mg/ml (1 ml/kg, max 60 ml), every 8 hours for a total of 6 doses

Normal Saline placebo

Normal Saline Placebo: (1 ml/kg, max 60 ml), administered every 8 hours for a total of 6 doses

Overall Number of Participants Analyzed 100 102
Median (Inter-Quartile Range)
Unit of Measure: mg Morphine/kg
1.46
(0.55 to 3.32)
1.28
(0.40 to 3.29)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Magnesium Group, Placebo Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.12
Comments [Not Specified]
Method Van Elteren test
Comments Randomization strata were defined by enrollment site, age group and hydroxyurea use within the last three months prior to enrollment.
3.Secondary Outcome
Title Hypotension Associated With Infusion
Hide Description For each study drug infusion, systolic blood pressure (SBP) was measured just prior to the start of the infusion and again every 10 minutes until 30 minutes until the end of the infusion. Hypotension was defined as a greater than 20% reduction in SBP relative to corresponding baseline measurement for any study drug infusion.
Time Frame Blood pressure will be monitored every 8 hours, concurrent with each infusion, and for 20-30 minutes after infusion completion, until discharge, up to 2 days post enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug
Arm/Group Title Magnesium Group Placebo Group
Hide Arm/Group Description:

Intravenous Magnesium Sulfate

Intravenous Magnesium Sulfate: 40 mg/kg (max 2.4 grams), infused at a concentration of 40 mg/ml (1 ml/kg, max 60 ml), every 8 hours for a total of 6 doses

Normal Saline placebo

Normal Saline Placebo: (1 ml/kg, max 60 ml), administered every 8 hours for a total of 6 doses

Overall Number of Participants Analyzed 101 103
Measure Type: Number
Unit of Measure: Participant
4 1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Magnesium Group, Placebo Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.39
Comments [Not Specified]
Method Mantel Haenszel
Comments Randomization strata were defined by enrollment site, age group and hydroxyurea use within the last three months prior to enrollment.
4.Secondary Outcome
Title Warm Sensation Associated With Study Drug Infusion
Hide Description Patient spontaneously reported feelings of warmth during any study drug infusion.
Time Frame Patient-reported warm sensation upon infusion will be monitored every 8 hours, concurrent with each infusion, and for 20-30 minutes after infusion completion, until discharge, up to 2 days post enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug.
Arm/Group Title Magnesium Group Placebo Group
Hide Arm/Group Description:

Intravenous Magnesium Sulfate

Intravenous Magnesium Sulfate: 40 mg/kg (max 2.4 grams), infused at a concentration of 40 mg/ml (1 ml/kg, max 60 ml), every 8 hours for a total of 6 doses

Normal Saline placebo

Normal Saline Placebo: (1 ml/kg, max 60 ml), administered every 8 hours for a total of 6 doses

Overall Number of Participants Analyzed 101 103
Measure Type: Number
Unit of Measure: Participant
26 2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Magnesium Group, Placebo Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method Mantel Haenszel
Comments Randomization strata were defined by enrollment site, age group and hydroxyurea use within the last three months prior to enrollment.
5.Secondary Outcome
Title Rehospitalization
Hide Description [Not Specified]
Time Frame Rehospitalization will be measured at 7 days post discharge and at the follow-up visit (on average, 30 days post discharge)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug who had known rehospitalization status within 7 days
Arm/Group Title Magnesium Group Placebo Group
Hide Arm/Group Description:

Intravenous Magnesium Sulfate

Intravenous Magnesium Sulfate: 40 mg/kg (max 2.4 grams), infused at a concentration of 40 mg/ml (1 ml/kg, max 60 ml), every 8 hours for a total of 6 doses

Normal Saline placebo

Normal Saline Placebo: (1 ml/kg, max 60 ml), administered every 8 hours for a total of 6 doses

Overall Number of Participants Analyzed 100 102
Measure Type: Number
Unit of Measure: Participant
12 7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Magnesium Group, Placebo Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.11
Comments [Not Specified]
Method Mantel Haenszel
Comments Randomization strata were defined by enrollment site, age group and hydroxyurea use within the last three months prior to enrollment.
6.Secondary Outcome
Title Development of Acute Chest Syndrome (ACS)
Hide Description [Not Specified]
Time Frame Patients will be monitored daily, on average, during their length of stay until discharge, up to 10 days post enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Magnesium Group Placebo Group
Hide Arm/Group Description:

Intravenous Magnesium Sulfate

Intravenous Magnesium Sulfate: 40 mg/kg (max 2.4 grams), infused at a concentration of 40 mg/ml (1 ml/kg, max 60 ml), every 8 hours for a total of 6 doses

Normal Saline placebo

Normal Saline Placebo: (1 ml/kg, max 60 ml), administered every 8 hours for a total of 6 doses

Overall Number of Participants Analyzed 101 103
Measure Type: Number
Unit of Measure: Paricipants
16 14
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Magnesium Group, Placebo Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.78
Comments [Not Specified]
Method Van Elteren test
Comments Randomization strata were defined by enrollment site, age group and hydroxyurea use within the last three months prior to enrollment.
7.Secondary Outcome
Title Hospital Length of Stay
Hide Description [Not Specified]
Time Frame Start of first study drug infusion to actual hospital discharge
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Magnesium Group Placebo Group
Hide Arm/Group Description:

Intravenous Magnesium Sulfate

Intravenous Magnesium Sulfate: 40 mg/kg (max 2.4 grams), infused at a concentration of 40 mg/ml (1 ml/kg, max 60 ml), every 8 hours for a total of 6 doses

Normal Saline placebo

Normal Saline Placebo: (1 ml/kg, max 60 ml), administered every 8 hours for a total of 6 doses

Overall Number of Participants Analyzed 100 102
Median (Inter-Quartile Range)
Unit of Measure: Hours
74.5
(39.5 to 123.5)
60.5
(37 to 122)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Magnesium Group, Placebo Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.46
Comments [Not Specified]
Method Van Elteren test
Comments Randomization strata were defined by enrollment site, age group and hydroxyurea use within the last three months prior to enrollment.
Time Frame [Not Specified]
Adverse Event Reporting Description Participant Flow and Baseline characteristics are reported for all randomized patients; however, adverse events only include the 204 (98%) who received study drug.
 
Arm/Group Title Magnesium Group Placebo Group
Hide Arm/Group Description Intravenous Magnesium Sulfate Intravenous Magnesium Sulfate: 40 mg/kg (max 2.4 grams), infused at a concentration of 40 mg/ml (1 ml/kg, max 60 ml), every 8 hours for a total of 6 doses Normal Saline placebo Normal Saline Placebo: (1 ml/kg, max 60 ml), administered every 8 hours for a total of 6 doses
All-Cause Mortality
Magnesium Group Placebo Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Magnesium Group Placebo Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   13/101 (12.87%)      12/103 (11.65%)    
Blood and lymphatic system disorders     
Acute chest syndrome   10/101 (9.90%)  10 7/103 (6.80%)  7
Hepatobiliary disorders     
Gallstones   1/101 (0.99%)  1 0/103 (0.00%)  0
Infections and infestations     
Appendicitis   1/101 (0.99%)  1 0/103 (0.00%)  0
Investigations     
Decreased hemoglobin   0/101 (0.00%)  0 4/103 (3.88%)  4
Respiratory, thoracic and mediastinal disorders     
Acute respiratory failure   1/101 (0.99%)  1 0/103 (0.00%)  0
Respiratory failure   0/101 (0.00%)  0 1/103 (0.97%)  1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Magnesium Group Placebo Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   66/101 (65.35%)      62/103 (60.19%)    
Blood and lymphatic system disorders     
Acute chest syndrome   6/101 (5.94%)  6 7/103 (6.80%)  7
Anemia   7/101 (6.93%)  7 7/103 (6.80%)  7
Gastrointestinal disorders     
Constipation   8/101 (7.92%)  8 11/103 (10.68%)  11
Emesis   10/101 (9.90%)  10 9/103 (8.74%)  9
Nausea   16/101 (15.84%)  16 19/103 (18.45%)  20
Vomiting   5/101 (4.95%)  5 11/103 (10.68%)  11
General disorders     
Fever   27/101 (26.73%)  31 26/103 (25.24%)  26
Warmth   8/101 (7.92%)  10 0/103 (0.00%)  0
Investigations     
Oxygen saturation decreased   8/101 (7.92%)  8 12/103 (11.65%)  12
Nervous system disorders     
Dizziness   6/101 (5.94%)  7 4/103 (3.88%)  4
Headache   12/101 (11.88%)  13 9/103 (8.74%)  11
Respiratory, thoracic and mediastinal disorders     
Cough   1/101 (0.99%)  1 6/103 (5.83%)  6
Hypoxia   7/101 (6.93%)  7 2/103 (1.94%)  2
Skin and subcutaneous tissue disorders     
Itching   12/101 (11.88%)  12 8/103 (7.77%)  8
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: David Brousseau MD, MS
Organization: Medical College of Wisconsin
Phone: 414-266-2625
Responsible Party: Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT01197417     History of Changes
Other Study ID Numbers: PECARN 025
First Submitted: August 31, 2010
First Posted: September 9, 2010
Results First Submitted: August 5, 2015
Results First Posted: September 7, 2015
Last Update Posted: January 27, 2016