Trial Outcomes & Findings for Effects of Magnesium on Individuals Undergoing Coronary Artery Bypass Graft Surgery (NCT NCT00041392)
NCT ID: NCT00041392
Last Updated: 2013-07-30
Results Overview
To characterize cognitive function over time, while minimizing potential redundancy in the cognitive measures, a factor analysis was performed on the cognitive test scores from baseline. We chose a four-factor solution, which represents 4 cognitive domains: verbal memory, abstraction and visuo-spatial orientation (executive function), visual memory and attention and concentration. To quantify overall cognitive function, a baseline cognitive index was first calculated as the mean of the 4 preoperative domain scores. The cognitive index score has a mean of zero and standard deviation of 0.5. Thus, any positive score is above the mean, any negative score is below the mean, and a score of 0.5 represents 1 SD above the mean. A continuous change score was then calculated by subtracting the baseline from the 6-week cognitive index. Negative scores indicate decline and positive scores indicate improvement.
COMPLETED
PHASE2
389 participants
Measured at baseline and 6 weeks
2013-07-30
Participant Flow
Hospital and preoperative clinic
Participant milestones
| Measure |
Magnesium
100 mg/kg magnesium
|
0.9 % Saline
100 mg/kg 0.9 % saline
|
|---|---|---|
|
Overall Study
STARTED
|
198
|
191
|
|
Overall Study
COMPLETED
|
198
|
191
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effects of Magnesium on Individuals Undergoing Coronary Artery Bypass Graft Surgery
Baseline characteristics by cohort
| Measure |
Magnesium
n=198 Participants
100 mg/kg magnesium
|
0.9 % Saline
n=191 Participants
100 mg/kg 0.9 % saline
|
Total
n=389 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
78 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
152 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
120 Participants
n=5 Participants
|
117 Participants
n=7 Participants
|
237 Participants
n=5 Participants
|
|
Age Continuous
|
68.6 years
STANDARD_DEVIATION 8.4 • n=5 Participants
|
68.4 years
STANDARD_DEVIATION 8.0 • n=7 Participants
|
68.5 years
STANDARD_DEVIATION 8.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
54 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
120 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
144 Participants
n=5 Participants
|
125 Participants
n=7 Participants
|
269 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
198 participants
n=5 Participants
|
191 participants
n=7 Participants
|
389 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Measured at baseline and 6 weeksTo characterize cognitive function over time, while minimizing potential redundancy in the cognitive measures, a factor analysis was performed on the cognitive test scores from baseline. We chose a four-factor solution, which represents 4 cognitive domains: verbal memory, abstraction and visuo-spatial orientation (executive function), visual memory and attention and concentration. To quantify overall cognitive function, a baseline cognitive index was first calculated as the mean of the 4 preoperative domain scores. The cognitive index score has a mean of zero and standard deviation of 0.5. Thus, any positive score is above the mean, any negative score is below the mean, and a score of 0.5 represents 1 SD above the mean. A continuous change score was then calculated by subtracting the baseline from the 6-week cognitive index. Negative scores indicate decline and positive scores indicate improvement.
Outcome measures
| Measure |
Magnesium
n=198 Participants
100 mg/kg magnesium
|
0.9 % Saline
n=191 Participants
100 mg/kg 0.9 % saline
|
|---|---|---|
|
Cognitive Function
|
0.07 Continuous cognitive change score
Standard Deviation 0.28
|
0.12 Continuous cognitive change score
Standard Deviation 0.28
|
Adverse Events
Magnesium
0.9 % Saline
Serious adverse events
| Measure |
Magnesium
n=198 participants at risk
100 mg/kg magnesium
|
0.9 % Saline
n=191 participants at risk
100 mg/kg 0.9 % saline
|
|---|---|---|
|
Immune system disorders
Fever
|
0.51%
1/198 • Number of events 2
|
0.52%
1/191 • Number of events 2
|
|
Cardiac disorders
Atrial fibrillation
|
0.51%
1/198 • Number of events 2
|
0.52%
1/191 • Number of events 2
|
|
Cardiac disorders
Ventricular tachycardia
|
1.5%
3/198 • Number of events 4
|
0.52%
1/191 • Number of events 4
|
|
Cardiac disorders
Pacemaker placement
|
2.0%
4/198 • Number of events 6
|
1.0%
2/191 • Number of events 6
|
|
Cardiac disorders
Cardiac arrest
|
0.51%
1/198 • Number of events 1
|
0.00%
0/191
|
|
Cardiac disorders
Myocardial infarction
|
0.51%
1/198 • Number of events 2
|
0.52%
1/191 • Number of events 2
|
|
Cardiac disorders
Congestive heart failure
|
0.51%
1/198 • Number of events 2
|
0.52%
1/191 • Number of events 2
|
|
Cardiac disorders
Hypotension
|
2.0%
4/198 • Number of events 4
|
0.00%
0/191
|
|
Cardiac disorders
Cardiac death
|
1.0%
2/198 • Number of events 3
|
0.52%
1/191 • Number of events 3
|
|
Gastrointestinal disorders
GI bleed
|
0.51%
1/198 • Number of events 2
|
0.52%
1/191 • Number of events 2
|
|
Gastrointestinal disorders
Small bowel obstruction
|
0.00%
0/198
|
0.52%
1/191 • Number of events 1
|
|
Infections and infestations
Urinary tract infection
|
0.51%
1/198 • Number of events 1
|
0.00%
0/191
|
|
Blood and lymphatic system disorders
Bleeding
|
4.0%
8/198 • Number of events 10
|
1.0%
2/191 • Number of events 10
|
|
Surgical and medical procedures
Reexploration for bleeding
|
1.5%
3/198 • Number of events 6
|
1.6%
3/191 • Number of events 6
|
|
Infections and infestations
Sternal wound infection
|
0.51%
1/198 • Number of events 2
|
0.52%
1/191 • Number of events 2
|
|
Nervous system disorders
Stroke
|
2.5%
5/198 • Number of events 11
|
3.1%
6/191 • Number of events 11
|
|
Infections and infestations
Cellulitis
|
0.51%
1/198 • Number of events 1
|
0.00%
0/191
|
|
Infections and infestations
Pneumonia
|
1.0%
2/198 • Number of events 5
|
1.6%
3/191 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.0%
2/198 • Number of events 10
|
4.2%
8/191 • Number of events 10
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
4.0%
8/198 • Number of events 14
|
3.1%
6/191 • Number of events 14
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
1.5%
3/198 • Number of events 6
|
1.6%
3/191 • Number of events 6
|
|
Renal and urinary disorders
Renal insufficiency
|
2.0%
4/198 • Number of events 5
|
0.52%
1/191 • Number of events 5
|
|
Renal and urinary disorders
Renal failure
|
1.5%
3/198 • Number of events 5
|
1.0%
2/191 • Number of events 5
|
Other adverse events
| Measure |
Magnesium
n=198 participants at risk
100 mg/kg magnesium
|
0.9 % Saline
n=191 participants at risk
100 mg/kg 0.9 % saline
|
|---|---|---|
|
Renal and urinary disorders
Renal Insufficiency
|
6.1%
12/198
|
2.1%
4/191
|
|
Blood and lymphatic system disorders
Postoperative bleeding
|
5.6%
11/198
|
4.2%
8/191
|
|
Cardiac disorders
Hypotension
|
5.6%
11/198
|
5.2%
10/191
|
|
Cardiac disorders
Anemia
|
8.1%
16/198
|
3.7%
7/191
|
|
Cardiac disorders
Atrial fibrillation
|
39.4%
78/198
|
34.6%
66/191
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
4.5%
9/198
|
7.3%
14/191
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place