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Field Administration of Stroke Therapy - Magnesium (FAST-MAG) Trial (FAST-MAG)

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ClinicalTrials.gov Identifier: NCT00059332
Recruitment Status : Completed
First Posted : April 24, 2003
Results First Posted : August 21, 2015
Last Update Posted : August 21, 2015
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Jeffrey L. Saver, University of California, Los Angeles

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Cerebrovascular Accident
Interventions Drug: Magnesium Sulfate
Drug: Normal Saline
Enrollment 1700
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Normal Saline Magnesium Sulfate
Hide Arm/Group Description Normal Saline: Paramedics initiate a loading dose of placebo normal saline IV over 15 minutes, followed after hospital arrival by a maintenance infusion of placebo normal saline IV over 24 hours. Magnesium Sulfate: Paramedics initiate a loading dose of 4 grams magnesium sulfate IV over 15 minutes, followed after hospital arrival by a maintenance infusion of 16 grams magnesium sulfate IV over 24 hours.
Period Title: Overall Study
Started 843 857
Completed 840 855
Not Completed 3 2
Reason Not Completed
Withdrawal by Subject             2             1
Lost to Follow-up             1             1
Arm/Group Title Normal Saline Magnesium Sulfate Total
Hide Arm/Group Description Normal Saline: Paramedics initiate a loading dose of placebo normal saline IV over 15 minutes, followed after hospital arrival by a maintenance infusion of placebo normal saline IV over 24 hours. Magnesium Sulfate: Paramedics initiate a loading dose of 4 grams magnesium sulfate IV over 15 minutes, followed after hospital arrival by a maintenance infusion of 16 grams magnesium sulfate IV over 24 hours. Total of all reporting groups
Overall Number of Baseline Participants 843 857 1700
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 843 participants 857 participants 1700 participants
69  (13.6) 69  (13.4) 69  (13.5)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 843 participants 857 participants 1700 participants
<60 years of age 239 242 481
60-75 years of age 284 278 562
>75 years of age 320 337 657
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 843 participants 857 participants 1700 participants
Female
367
  43.5%
358
  41.8%
725
  42.6%
Male
476
  56.5%
499
  58.2%
975
  57.4%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 843 participants 857 participants 1700 participants
Hispanic or Latino
206
  24.4%
196
  22.9%
402
  23.6%
Not Hispanic or Latino
637
  75.6%
661
  77.1%
1298
  76.4%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 843 participants 857 participants 1700 participants
American Indian or Alaska Native
5
   0.6%
4
   0.5%
9
   0.5%
Asian
62
   7.4%
77
   9.0%
139
   8.2%
Native Hawaiian or Other Pacific Islander
2
   0.2%
6
   0.7%
8
   0.5%
Black or African American
113
  13.4%
106
  12.4%
219
  12.9%
White
661
  78.4%
664
  77.5%
1325
  77.9%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Medical History  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 843 participants 857 participants 1700 participants
Hypertension 648 671 1319
Diabetes 188 189 377
Hyperlipidimia 407 398 805
Atrial fibrillation 175 194 369
Myocardial infarction 82 94 176
Tobacco use 158 139 297
Alcohol use 328 326 654
Prestroke function - Living at home  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 843 participants 857 participants 1700 participants
823 834 1657
Los Angeles Motor Scale at hospital arrival   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 843 participants 857 participants 1700 participants
3.3  (2.2) 3.4  (2.3) 3.4  (2.3)
[1]
Measure Description: The Los Angeles Motor Scale (LAMS) Facial droop (sub score is 0-1) Absent 0 Present 1 Arm drift (sub score range is 0-2) Absent 0 Drifts down 1 Falls rapidly 2 Grip strength (sub score range is 0-2) Normal 0 Weak grip 1 No grip 2 The sub scales are summed to obtain a total score. Total Score Range is 0-5. Lower values on the scale represent better outcomes and Higher values on the scale represent worse outcomes.
National Institute of Health Stroke Scale (NIHSS) at hospital arrival   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 843 participants 857 participants 1700 participants
11.2  (9.8) 11.5  (9.9) 11.3  (9.9)
[1]
Measure Description:

The National Institute of Health Stroke Scale (NIHSS) is a measure of neurologic deficit. Total Score range 0-42, with higher scores indicating greater severity. The 11 domains assessed are:

1a-c Level of consciousness 2. Best Gaze 3. Visual 4. Facial Palsy 5a. Motor left arm 5b. Motor right arm 6a. Motor left leg 6b. Motor right leg 7. Limb Ataxia 8. Sensory 9. Best Language 10. Dysarthria 11. Extinction and Inattention

Intravenous tissue plasminogen activator (t-PA) in patients with cerebral ischemia  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 843 participants 857 participants 1700 participants
205 242 447
Final Diagnosis  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 843 participants 857 participants 1700 participants
Cerebral Ischemia 613 632 1245
Intracranial Hemorrhage 192 195 387
Cerebrovascular-mimicking condition 37 30 67
1.Primary Outcome
Title Modified Rankin Scale
Hide Description

Modified Rankin Scales (mRS) is a measure of global disability. Total Scale range is 0-6, with lower values indicating better outcomes.

0 No symptoms at all

  1. No significant disability despite symptoms; able to carry out all usual duties and activities
  2. Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance
  3. Moderate disability; requiring some help, but able to walk without assistance
  4. Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance
  5. Severe disability; bedridden, incontinent and requiring constant nursing care and attention
  6. Dead
Time Frame 3 months after stroke onset
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Normal Saline Magnesium Sulfate
Hide Arm/Group Description:
Normal Saline: Paramedics initiate a loading dose of placebo normal saline IV over 15 minutes, followed after hospital arrival by a maintenance infusion of placebo normal saline IV over 24 hours.
Magnesium Sulfate: Paramedics initiate a loading dose of 4 grams magnesium sulfate IV over 15 minutes, followed after hospital arrival by a maintenance infusion of 16 grams magnesium sulfate IV over 24 hours.
Overall Number of Participants Analyzed 843 857
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
2
(1 to 4)
2
(1 to 5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Normal Saline, Magnesium Sulfate
Comments For the primary efficacy analysis, data were analyzed to test the null hypothesis that the distribution of scores over all 7 levels of the modified Rankin Scale at Day 90 was identical in the magnesium sulfate and placebo groups, vs. the one-sided alternative that the distribution of scores is shifted lower in the active magnesium sulfate therapy group. The statistic used to test the primary hypothesis was the Cochran-Mantel-Haenszel test statistic stratified by transport vehicle.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.28
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
2.Secondary Outcome
Title Modified Rankin Score of 0 or 1
Hide Description Minimal or no disability based on the modified Rankin score
Time Frame 3 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Normal Saline Magnesium Sulfate
Hide Arm/Group Description:
Normal Saline: Paramedics initiate a loading dose of placebo normal saline IV over 15 minutes, followed after hospital arrival by a maintenance infusion of placebo normal saline IV over 24 hours.
Magnesium Sulfate: Paramedics initiate a loading dose of 4 grams magnesium sulfate IV over 15 minutes, followed after hospital arrival by a maintenance infusion of 16 grams magnesium sulfate IV over 24 hours.
Overall Number of Participants Analyzed 843 857
Measure Type: Number
Unit of Measure: participants
311 313
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Normal Saline, Magnesium Sulfate
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.87
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.98
Confidence Interval (2-Sided) 95%
0.81 to 1.20
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Modified Rankin Score ≤2
Hide Description Functional independence based on modified Rankin score
Time Frame 3 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Normal Saline Magnesium Sulfate
Hide Arm/Group Description:
Normal Saline: Paramedics initiate a loading dose of placebo normal saline IV over 15 minutes, followed after hospital arrival by a maintenance infusion of placebo normal saline IV over 24 hours.
Magnesium Sulfate: Paramedics initiate a loading dose of 4 grams magnesium sulfate IV over 15 minutes, followed after hospital arrival by a maintenance infusion of 16 grams magnesium sulfate IV over 24 hours.
Overall Number of Participants Analyzed 843 857
Measure Type: Number
Unit of Measure: participants
445 449
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Normal Saline, Magnesium Sulfate
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.87
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.98
Confidence Interval (2-Sided) 95%
0.81 to 1.19
Estimation Comments [Not Specified]
4.Secondary Outcome
Title NIH Stroke Scale
Hide Description

The National Institute of Health Stroke Scale (NIHSS) is a measure of neurologic deficit. Total Score range 0-42, with higher scores indicating greater severity. The 11 domains assessed are:

1a-c Level of consciousness 2. Best Gaze 3. Visual 4. Facial Palsy 5a. Motor left arm 5b. Motor right arm 6a. Motor left leg 6b. Motor right leg 7. Limb Ataxia 8. Sensory 9. Best Language 10. Dysarthria 11. Extinction and Inattention

Time Frame 3 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Normal Saline Magnesium Sulfate
Hide Arm/Group Description:
Normal Saline: Paramedics initiate a loading dose of placebo normal saline IV over 15 minutes, followed after hospital arrival by a maintenance infusion of placebo normal saline IV over 24 hours.
Magnesium Sulfate: Paramedics initiate a loading dose of 4 grams magnesium sulfate IV over 15 minutes, followed after hospital arrival by a maintenance infusion of 16 grams magnesium sulfate IV over 24 hours.
Overall Number of Participants Analyzed 843 857
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
3
(0 to 42)
3
(0 to 19)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Normal Saline, Magnesium Sulfate
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2760
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
5.Secondary Outcome
Title Barthel Index
Hide Description

The Barthel Index is a measure of activities of daily living. Total score is calculated by addition of subscale scores. Total score range is 0-100, with higher scores indicating better outcomes. The ten subitems are:

FEEDING (Subscale range is 0-10) BATHING (Subscale range is 0-5) GROOMING (Subscale range is 0-5) DRESSING (Subscale range is 0-10) BOWELS (Subscale range is 0-10) BLADDER (Subscale range is 0-10) TOILET USE (Subscale range is 0-10) TRANSFERS (Subscale range is 0-15) MOBILITY (Subscale range is 0-15) STAIRS (Subscale range is 0-10)

Time Frame 3 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Normal Saline Magnesium Sulfate
Hide Arm/Group Description:
Normal Saline: Paramedics initiate a loading dose of placebo normal saline IV over 15 minutes, followed after hospital arrival by a maintenance infusion of placebo normal saline IV over 24 hours.
Magnesium Sulfate: Paramedics initiate a loading dose of 4 grams magnesium sulfate IV over 15 minutes, followed after hospital arrival by a maintenance infusion of 16 grams magnesium sulfate IV over 24 hours.
Overall Number of Participants Analyzed 843 857
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
95
(20 to 100)
90
(30 to 100)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Normal Saline, Magnesium Sulfate
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3912
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
6.Secondary Outcome
Title Stroke Impact Scale
Hide Description

The Stroke Impact Scale (SIS) is a measure of stroke-specific quality of life. The scale assesses 8 domains. Scores for each domain range from 0-100, with higher scores indicating better outcomes.

  1. Physical problems
  2. Memory and thinking
  3. Mood and emotions
  4. Communication, reading and understanding
  5. Daily activities
  6. Mobility at home and in the community
  7. Affected hand use
  8. Hobbies and activities participation
Time Frame 3 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Normal Saline Magnesium Sulfate
Hide Arm/Group Description:
Normal Saline: Paramedics initiate a loading dose of placebo normal saline IV over 15 minutes, followed after hospital arrival by a maintenance infusion of placebo normal saline IV over 24 hours.
Magnesium Sulfate: Paramedics initiate a loading dose of 4 grams magnesium sulfate IV over 15 minutes, followed after hospital arrival by a maintenance infusion of 16 grams magnesium sulfate IV over 24 hours.
Overall Number of Participants Analyzed 843 857
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
65
(5.4 to 91.7)
67
(11.7 to 91.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Normal Saline, Magnesium Sulfate
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3230
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
7.Secondary Outcome
Title Serious Adverse Events
Hide Description [Not Specified]
Time Frame 3 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Normal Saline Magnesium Sulfate
Hide Arm/Group Description:
Normal Saline: Paramedics initiate a loading dose of placebo normal saline IV over 15 minutes, followed after hospital arrival by a maintenance infusion of placebo normal saline IV over 24 hours.
Magnesium Sulfate: Paramedics initiate a loading dose of 4 grams magnesium sulfate IV over 15 minutes, followed after hospital arrival by a maintenance infusion of 16 grams magnesium sulfate IV over 24 hours.
Overall Number of Participants Analyzed 843 857
Measure Type: Number
Unit of Measure: participants
422 439
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Normal Saline, Magnesium Sulfate
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.95
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.05
Confidence Interval (2-Sided) 95%
0.87 to 1.27
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Symptomatic Intracranial Hemorrhage
Hide Description [Not Specified]
Time Frame 3 month
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Normal Saline Magnesium Sulfate
Hide Arm/Group Description:
Normal Saline: Paramedics initiate a loading dose of placebo normal saline IV over 15 minutes, followed after hospital arrival by a maintenance infusion of placebo normal saline IV over 24 hours.
Magnesium Sulfate: Paramedics initiate a loading dose of 4 grams magnesium sulfate IV over 15 minutes, followed after hospital arrival by a maintenance infusion of 16 grams magnesium sulfate IV over 24 hours.
Overall Number of Participants Analyzed 843 857
Measure Type: Number
Unit of Measure: participants
28 18
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Normal Saline, Magnesium Sulfate
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 Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.62
Confidence Interval (2-Sided) 95%
0.34 to 1.14
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Mortality
Hide Description [Not Specified]
Time Frame 3 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Normal Saline Magnesium Sulfate
Hide Arm/Group Description:
Normal Saline: Paramedics initiate a loading dose of placebo normal saline IV over 15 minutes, followed after hospital arrival by a maintenance infusion of placebo normal saline IV over 24 hours.
Magnesium Sulfate: Paramedics initiate a loading dose of 4 grams magnesium sulfate IV over 15 minutes, followed after hospital arrival by a maintenance infusion of 16 grams magnesium sulfate IV over 24 hours.
Overall Number of Participants Analyzed 843 857
Measure Type: Number
Unit of Measure: participants
131 132
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Normal Saline, Magnesium Sulfate
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.95
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.99
Confidence Interval (2-Sided) 95%
0.76 to 1.29
Estimation Comments [Not Specified]
Time Frame 3 months after stroke onset
Adverse Event Reporting Description A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
 
Arm/Group Title Normal Saline Magnesium Sulfate
Hide Arm/Group Description Normal Saline: Paramedics initiate a loading dose of placebo normal saline IV over 15 minutes, followed after hospital arrival by a maintenance infusion of placebo normal saline IV over 24 hours. Magnesium Sulfate: Paramedics initiate a loading dose of 4 grams magnesium sulfate IV over 15 minutes, followed after hospital arrival by a maintenance infusion of 16 grams magnesium sulfate IV over 24 hours.
All-Cause Mortality
Normal Saline Magnesium Sulfate
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Normal Saline Magnesium Sulfate
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   422/843 (50.06%)      439/857 (51.23%)    
Blood and lymphatic system disorders     
Anemia  1  8/843 (0.95%)  12/857 (1.40%) 
Disseminated intravascular coagulation  1  0/843 (0.00%)  1/857 (0.12%) 
Leukocytosis  1  0/843 (0.00%)  1/857 (0.12%) 
Neutropenia  1  0/843 (0.00%)  1/857 (0.12%) 
Thrombocytopenia  1  0/843 (0.00%)  1/857 (0.12%) 
Cardiac disorders     
Acute myocardial infarction  1  1/843 (0.12%)  2/857 (0.23%) 
Angina pectoris  1  5/843 (0.59%)  2/857 (0.23%) 
Atrial fibrillation  1  41/843 (4.86%)  43/857 (5.02%) 
Atrial flutter  1  0/843 (0.00%)  1/857 (0.12%) 
Atrioventricular block  1  0/843 (0.00%)  3/857 (0.35%) 
Atrioventricular block complete  1  1/843 (0.12%)  0/857 (0.00%) 
Bradycardia  1  22/843 (2.61%)  28/857 (3.27%) 
Cardiac arrest  1  18/843 (2.14%)  21/857 (2.45%) 
Cardiac discomfort  1  1/843 (0.12%)  0/857 (0.00%) 
Cardiac failure  1  0/843 (0.00%)  1/857 (0.12%) 
Cardiac failure congestive  1  10/843 (1.19%)  7/857 (0.82%) 
Cardiac tamponade  1  0/843 (0.00%)  1/857 (0.12%) 
Cardio-respiratory arrest  1  5/843 (0.59%)  4/857 (0.47%) 
Myocardial infarction  1  10/843 (1.19%)  13/857 (1.52%) 
Myocardial ischaemia  1  0/843 (0.00%)  2/857 (0.23%) 
Pericardial haemorrhage  1  0/843 (0.00%)  1/857 (0.12%) 
Pericarditis  1  1/843 (0.12%)  0/857 (0.00%) 
Sick sinus syndrome  1  4/843 (0.47%)  4/857 (0.47%) 
Sinus tachycardia  1  0/843 (0.00%)  1/857 (0.12%) 
Supraventricular tachycardia  1  2/843 (0.24%)  2/857 (0.23%) 
Syncope  1  2/843 (0.24%)  1/857 (0.12%) 
Torsade de pointes  1  2/843 (0.24%)  1/857 (0.12%) 
Ventricular fibrillation  1  0/843 (0.00%)  1/857 (0.12%) 
Ventricular tachycardia  1  3/843 (0.36%)  4/857 (0.47%) 
Congenital, familial and genetic disorders     
Arteriovenous malformation  1  2/843 (0.24%)  0/857 (0.00%) 
Atrial septal defect  1  2/843 (0.24%)  0/857 (0.00%) 
Endocrine disorders     
Hyperparathyroidism  1  0/843 (0.00%)  1/857 (0.12%) 
Inappropriate antidiuretic hormone secretion  1  1/843 (0.12%)  0/857 (0.00%) 
Gastrointestinal disorders     
Abdominal hernia obstructive  1  1/843 (0.12%)  0/857 (0.00%) 
Abdominal pain  1  0/843 (0.00%)  1/857 (0.12%) 
Constipation  1  2/843 (0.24%)  0/857 (0.00%) 
Diarrhoea  1  1/843 (0.12%)  1/857 (0.12%) 
Dyspepsia  1  0/843 (0.00%)  1/857 (0.12%) 
Dysphagia  1  44/843 (5.22%)  45/857 (5.25%) 
Enterocolitis  1  1/843 (0.12%)  0/857 (0.00%) 
Gastrointestinal haemorrhage  1  9/843 (1.07%)  4/857 (0.47%) 
Gastrooesophageal reflux disease  1  1/843 (0.12%)  0/857 (0.00%) 
Haemorrhoids  1  0/843 (0.00%)  1/857 (0.12%) 
Ileus  1  1/843 (0.12%)  2/857 (0.23%) 
Large intestine perforation  1  0/843 (0.00%)  1/857 (0.12%) 
Oesophagitis  1  0/843 (0.00%)  1/857 (0.12%) 
Pancreatitis  1  0/843 (0.00%)  1/857 (0.12%) 
Parotitis  1  0/843 (0.00%)  1/857 (0.12%) 
Pneumoperitoneum  1  1/843 (0.12%)  0/857 (0.00%) 
Rectal ulcer  1  1/843 (0.12%)  0/857 (0.00%) 
Retroperitoneal haematoma  1  1/843 (0.12%)  0/857 (0.00%) 
Small intestinal obstruction  1  1/843 (0.12%)  0/857 (0.00%) 
Vomiting  1  2/843 (0.24%)  1/857 (0.12%) 
General disorders     
Asthenia  1  1/843 (0.12%)  3/857 (0.35%) 
Chest pain  1  2/843 (0.24%)  3/857 (0.35%) 
Fatigue  1  0/843 (0.00%)  1/857 (0.12%) 
Non-cardiac chest pain  1  1/843 (0.12%)  0/857 (0.00%) 
Pelvic mass  1  0/843 (0.00%)  1/857 (0.12%) 
Pyrexia  1  0/843 (0.00%)  2/857 (0.23%) 
Hepatobiliary disorders     
Cholecystitis  1  0/843 (0.00%)  1/857 (0.12%) 
Cholecystitis acute  1  1/843 (0.12%)  1/857 (0.12%) 
Cholelithiasis  1  1/843 (0.12%)  0/857 (0.00%) 
Hepatitis  1  1/843 (0.12%)  0/857 (0.00%) 
Jaundice  1  1/843 (0.12%)  0/857 (0.00%) 
Immune system disorders     
Anaphylactic reaction  1  2/843 (0.24%)  0/857 (0.00%) 
Hypersensitivity  1  2/843 (0.24%)  0/857 (0.00%) 
Infections and infestations     
Bacteraemia  1  0/843 (0.00%)  1/857 (0.12%) 
Cellulitis  1  0/843 (0.00%)  1/857 (0.12%) 
Device related infection  1  0/843 (0.00%)  1/857 (0.12%) 
Diverticulitis  1  1/843 (0.12%)  0/857 (0.00%) 
Endocarditis  1  0/843 (0.00%)  2/857 (0.23%) 
Herpes zoster  1  1/843 (0.12%)  0/857 (0.00%) 
Lung abscess  1  1/843 (0.12%)  0/857 (0.00%) 
Pneumonia  1  22/843 (2.61%)  36/857 (4.20%) 
Sepsis  1  12/843 (1.42%)  21/857 (2.45%) 
Septic shock  1  2/843 (0.24%)  1/857 (0.12%) 
Tuberculosis  1  0/843 (0.00%)  1/857 (0.12%) 
Urinary tract infection  1  17/843 (2.02%)  7/857 (0.82%) 
Urosepsis  1  2/843 (0.24%)  2/857 (0.23%) 
Wound infection  1  1/843 (0.12%)  1/857 (0.12%) 
Injury, poisoning and procedural complications     
Accidental poisoning  1  1/843 (0.12%)  0/857 (0.00%) 
Ankle fracture  1  0/843 (0.00%)  1/857 (0.12%) 
Brain herniation  1  2/843 (0.24%)  4/857 (0.47%) 
Cardiac valve replacement complication  1  0/843 (0.00%)  1/857 (0.12%) 
Concussion  1  0/843 (0.00%)  1/857 (0.12%) 
Device malfunction  1  1/843 (0.12%)  0/857 (0.00%) 
Fall  1  0/843 (0.00%)  1/857 (0.12%) 
Feeding tube complication  1  0/843 (0.00%)  1/857 (0.12%) 
Fracture  1  1/843 (0.12%)  0/857 (0.00%) 
Fractured sacrum  1  0/843 (0.00%)  1/857 (0.12%) 
Overdose  1  1/843 (0.12%)  0/857 (0.00%) 
Rib fracture  1  1/843 (0.12%)  1/857 (0.12%) 
Shunt malfunction  1  0/843 (0.00%)  1/857 (0.12%) 
Subdural haematoma  1  0/843 (0.00%)  1/857 (0.12%) 
Subdural haemorrhage  1  0/843 (0.00%)  2/857 (0.23%) 
Tracheostomy malfunction  1  1/843 (0.12%)  0/857 (0.00%) 
Upper limb fracture  1  1/843 (0.12%)  0/857 (0.00%) 
Wound dehiscence  1  0/843 (0.00%)  1/857 (0.12%) 
Wound necrosis  1  0/843 (0.00%)  1/857 (0.12%) 
Investigations     
Coagulation time prolonged  1  0/843 (0.00%)  1/857 (0.12%) 
Metabolism and nutrition disorders     
Dehydration  1  3/843 (0.36%)  2/857 (0.23%) 
Hyperglycaemia  1  1/843 (0.12%)  0/857 (0.00%) 
Hypernatraemia  1  1/843 (0.12%)  0/857 (0.00%) 
Hypoglycaemia  1  1/843 (0.12%)  3/857 (0.35%) 
Hypokalaemia  1  1/843 (0.12%)  0/857 (0.00%) 
Hyponatraemia  1  1/843 (0.12%)  2/857 (0.23%) 
Musculoskeletal and connective tissue disorders     
Muscular weakness  1  1/843 (0.12%)  0/857 (0.00%) 
Musculoskeletal chest pain  1  1/843 (0.12%)  0/857 (0.00%) 
Musculoskeletal pain  1  1/843 (0.12%)  0/857 (0.00%) 
Osteoarthritis  1  1/843 (0.12%)  0/857 (0.00%) 
Spinal osteoarthritis  1  0/843 (0.00%)  1/857 (0.12%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Brain cancer metastatic  1  1/843 (0.12%)  0/857 (0.00%) 
Brain neoplasm malignant  1  0/843 (0.00%)  1/857 (0.12%) 
Breast cancer metastatic  1  1/843 (0.12%)  0/857 (0.00%) 
Cardiac myxoma  1  1/843 (0.12%)  0/857 (0.00%) 
Colon cancer  1  1/843 (0.12%)  0/857 (0.00%) 
Gastric cancer  1  2/843 (0.24%)  0/857 (0.00%) 
Glioblastoma  1  1/843 (0.12%)  0/857 (0.00%) 
Hepatic cancer metastatic  1  0/843 (0.00%)  1/857 (0.12%) 
Hepatic neoplasm malignant  1  1/843 (0.12%)  0/857 (0.00%) 
Lung neoplasm malignant  1  2/843 (0.24%)  1/857 (0.12%) 
Malignant melanoma  1  1/843 (0.12%)  0/857 (0.00%) 
Maxillofacial sinus neoplasm  1  0/843 (0.00%)  1/857 (0.12%) 
Meningioma  1  0/843 (0.00%)  1/857 (0.12%) 
Metastases to central nervous system  1  1/843 (0.12%)  0/857 (0.00%) 
Metastasis  1  0/843 (0.00%)  1/857 (0.12%) 
Neoplasm malignant  1  1/843 (0.12%)  1/857 (0.12%) 
Pancreatic carcinoma  1  0/843 (0.00%)  1/857 (0.12%) 
Pancreatic carcinoma metastatic  1  1/843 (0.12%)  0/857 (0.00%) 
Parathyroid tumour benign  1  1/843 (0.12%)  0/857 (0.00%) 
Primitive neuroectodermal tumour  1  1/843 (0.12%)  0/857 (0.00%) 
Renal cancer  1  1/843 (0.12%)  0/857 (0.00%) 
Renal cancer metastatic  1  1/843 (0.12%)  0/857 (0.00%) 
Uterine leiomyoma  1  1/843 (0.12%)  0/857 (0.00%) 
Nervous system disorders     
Agitation  1  1/843 (0.12%)  0/857 (0.00%) 
Brain compression  1  1/843 (0.12%)  0/857 (0.00%) 
Brain injury  1  3/843 (0.36%)  1/857 (0.12%) 
Brain oedema  1  22/843 (2.61%)  16/857 (1.87%) 
Carotid artery stenosis  1  2/843 (0.24%)  4/857 (0.47%) 
Cerebral haemorrhage  1  25/843 (2.97%)  39/857 (4.55%) 
Cerebral infarction  1  37/843 (4.39%)  32/857 (3.73%) 
Cerebral ischaemia  1  1/843 (0.12%)  2/857 (0.23%) 
Cerebrovascular accident  1  11/843 (1.30%)  4/857 (0.47%) 
Complicated migraine  1  0/843 (0.00%)  1/857 (0.12%) 
Convulsion  1  4/843 (0.47%)  7/857 (0.82%) 
Cytotoxic oedema  1  0/843 (0.00%)  3/857 (0.35%) 
Depressed level of consciousness  1  2/843 (0.24%)  1/857 (0.12%) 
Haemorrhage intracranial  1  2/843 (0.24%)  1/857 (0.12%) 
Haemorrhagic cerebral infarction  1  19/843 (2.25%)  13/857 (1.52%) 
Haemorrhagic transformation stroke  1  6/843 (0.71%)  2/857 (0.23%) 
Headache  1  2/843 (0.24%)  1/857 (0.12%) 
Hemiparesis  1  0/843 (0.00%)  1/857 (0.12%) 
Hydrocephalus  1  9/843 (1.07%)  5/857 (0.58%) 
Intracranial pressure increased  1  0/843 (0.00%)  2/857 (0.23%) 
Intraventricular haemorrhage  1  1/843 (0.12%)  0/857 (0.00%) 
Ischaemic stroke  1  2/843 (0.24%)  3/857 (0.35%) 
Loss of consciousness  1  0/843 (0.00%)  1/857 (0.12%) 
Migraine  1  0/843 (0.00%)  1/857 (0.12%) 
Neurological decompensation  1  103/843 (12.22%)  105/857 (12.25%) 
Paraesthesia  1  1/843 (0.12%)  1/857 (0.12%) 
Sensory disturbance  1  1/843 (0.12%)  0/857 (0.00%) 
Status epilepticus  1  3/843 (0.36%)  0/857 (0.00%) 
Subarachnoid haemorrhage  1  3/843 (0.36%)  0/857 (0.00%) 
Syncope  1  3/843 (0.36%)  1/857 (0.12%) 
Transient ischaemic attack  1  9/843 (1.07%)  25/857 (2.92%) 
Psychiatric disorders     
Agitation  1  1/843 (0.12%)  1/857 (0.12%) 
Alcohol withdrawal syndrome  1  2/843 (0.24%)  0/857 (0.00%) 
Anxiety  1  2/843 (0.24%)  2/857 (0.23%) 
Confusional state  1  1/843 (0.12%)  3/857 (0.35%) 
Depression  1  1/843 (0.12%)  0/857 (0.00%) 
Mental status changes  1  0/843 (0.00%)  1/857 (0.12%) 
Psychosomatic disease  1  0/843 (0.00%)  1/857 (0.12%) 
Renal and urinary disorders     
Calculus urinary  1  0/843 (0.00%)  1/857 (0.12%) 
Haematuria  1  1/843 (0.12%)  0/857 (0.00%) 
Nephritis interstitial  1  1/843 (0.12%)  0/857 (0.00%) 
Renal failure  1  1/843 (0.12%)  2/857 (0.23%) 
Renal failure acute  1  6/843 (0.71%)  0/857 (0.00%) 
Epistaxis  1  0/843 (0.00%)  1/857 (0.12%) 
Respiratory, thoracic and mediastinal disorders     
Acute respiratory failure  1  1/843 (0.12%)  1/857 (0.12%) 
Bronchial secretion retention  1  0/843 (0.00%)  1/857 (0.12%) 
Dyspnoea  1  16/843 (1.90%)  34/857 (3.97%) 
Haemothorax  1  1/843 (0.12%)  0/857 (0.00%) 
Laryngeal disorder  1  1/843 (0.12%)  0/857 (0.00%) 
Pneumonia aspiration  1  3/843 (0.36%)  4/857 (0.47%) 
Pneumothorax  1  0/843 (0.00%)  1/857 (0.12%) 
Pulmonary embolism  1  9/843 (1.07%)  14/857 (1.63%) 
Pulmonary oedema  1  1/843 (0.12%)  7/857 (0.82%) 
Respiratory distress  1  3/843 (0.36%)  2/857 (0.23%) 
Respiratory failure  1  8/843 (0.95%)  5/857 (0.58%) 
Skin and subcutaneous tissue disorders     
Angioedema  1  1/843 (0.12%)  0/857 (0.00%) 
Decubitus ulcer  1  0/843 (0.00%)  1/857 (0.12%) 
Surgical and medical procedures     
Aortic valve replacement  1  0/843 (0.00%)  1/857 (0.12%) 
Carotid endarterectomy  1  4/843 (0.47%)  3/857 (0.35%) 
Cranioplasty  1  1/843 (0.12%)  0/857 (0.00%) 
Craniotomy  1  5/843 (0.59%)  2/857 (0.23%) 
Endotracheal intubation  1  0/843 (0.00%)  1/857 (0.12%) 
Haematoma evacuation  1  2/843 (0.24%)  2/857 (0.23%) 
Hip arthroplasty  1  0/843 (0.00%)  1/857 (0.12%) 
Lung lobectomy  1  1/843 (0.12%)  0/857 (0.00%) 
Medical device implantation  1  0/843 (0.00%)  1/857 (0.12%) 
Mitral valve replacement  1  0/843 (0.00%)  1/857 (0.12%) 
Transfusion  1  1/843 (0.12%)  0/857 (0.00%) 
Ventricular drainage  1  2/843 (0.24%)  2/857 (0.23%) 
Vascular disorders     
Aortic aneurysm  1  1/843 (0.12%)  0/857 (0.00%) 
Carotid artery dissection  1  0/843 (0.00%)  1/857 (0.12%) 
Deep vein thrombosis  1  31/843 (3.68%)  36/857 (4.20%) 
Gangrene  1  1/843 (0.12%)  0/857 (0.00%) 
Haematoma  1  1/843 (0.12%)  1/857 (0.12%) 
Haemorrhage  1  2/843 (0.24%)  0/857 (0.00%) 
Hypertension  1  0/843 (0.00%)  1/857 (0.12%) 
Hypertensive crisis  1  0/843 (0.00%)  1/857 (0.12%) 
Hypotension  1  30/843 (3.56%)  59/857 (6.88%) 
Malignant hypertension  1  1/843 (0.12%)  0/857 (0.00%) 
Neurogenic shock  1  0/843 (0.00%)  1/857 (0.12%) 
Orthostatic hypotension  1  0/843 (0.00%)  3/857 (0.35%) 
Peripheral vascular disorder  1  2/843 (0.24%)  1/857 (0.12%) 
Syncope  1  0/843 (0.00%)  2/857 (0.23%) 
Vasospasm  1  1/843 (0.12%)  0/857 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Normal Saline Magnesium Sulfate
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   331/843 (39.26%)      329/857 (38.39%)    
Blood and lymphatic system disorders     
Hypokalaemia  1  214/843 (25.39%)  233 205/857 (23.92%)  217
General disorders     
Headache  1  167/843 (19.81%)  173 178/857 (20.77%)  184
Renal and urinary disorders     
Urinary tract infection  1  133/843 (15.78%)  142 138/857 (16.10%)  152
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
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: Dr. Jeffrey Saver
Organization: UCLA, David Geffen School of Medicine
Phone: 310-794-6379
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jeffrey L. Saver, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT00059332     History of Changes
Other Study ID Numbers: U01NS044364 ( U.S. NIH Grant/Contract )
U01NS044364 ( U.S. NIH Grant/Contract )
First Submitted: April 23, 2003
First Posted: April 24, 2003
Results First Submitted: June 9, 2015
Results First Posted: August 21, 2015
Last Update Posted: August 21, 2015