Effects of Magnesium on Individuals Undergoing Coronary Artery Bypass Graft Surgery
NCT ID: NCT00041392
Last Updated: 2013-07-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
389 participants
INTERVENTIONAL
2001-12-31
2009-05-31
Brief Summary
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Detailed Description
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Approximately 400,000 individuals undergo heart operations each year and cognitive impairment occurs frequently following surgery. An increasing number of these individuals are elderly and are particularly susceptible to cognitive dysfunction following surgery. Cognitive impairment is most notable in the early stages following heart surgery, but it may persist in some individuals. While many people think cognitive impairment is subtle, transient, or subclinical, perioperative decline is associated with 5-year cognitive deterioration and reduced quality of life. Multiple strategies, both clinical and pharmacological, have been proposed to reduce the central nervous system dysfunction associated with heart surgery. However, most strategies have been unsuccessful, met with limited success, or are unrealistic from a cost or risk-benefit ratio for the majority of people. This study will examine the effectiveness of supplemental magnesium at preventing the cognitive decline associated with heart surgery.
DESIGN NARRATIVE:
This study will examine the effect of supplemental magnesium on the neurocognitive function of individuals undergoing CABG surgery. The two hypotheses to be tested include the following: 1) therapeutic levels of magnesium reduce post-operative neurocognitive dysfunction after heart surgery; and 2) therapeutic magnesium levels protect quality of life through reduced cognitive dysfunction after heart surgery. This double-blind study will enroll 400 individuals and randomly assign them to either the treatment group, which will receive 100 mg/kg of magnesium, or to the control group. Anesthesia management will be standardized to minimize any impact that anesthesia may have on neurologic or neuropsychologic outcome. Neurocognitive testing will be conducted prior to surgery, and 6 weeks and 1 year following surgery.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Magnesium
100 mg/kg magnesium
Magnesium
100 mg/kg
0.9 % saline
100 mg/kg 0.9 % saline
0.9% saline
Placebo
Interventions
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Magnesium
100 mg/kg
0.9% saline
Placebo
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* History of psychiatric illness
55 Years
ALL
No
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
Duke University
OTHER
Responsible Party
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Principal Investigators
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Mark F. Newman, MD
Role: STUDY_CHAIR
Duke University
Locations
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Duke University Medical Center
Durham, North Carolina, United States
Countries
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References
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Mathew JP, White WD, Schinderle DB, Podgoreanu MV, Berger M, Milano CA, Laskowitz DT, Stafford-Smith M, Blumenthal JA, Newman MF; Neurologic Outcome Research Group (NORG) of The Duke Heart Center. Intraoperative magnesium administration does not improve neurocognitive function after cardiac surgery. Stroke. 2013 Dec;44(12):3407-13. doi: 10.1161/STROKEAHA.113.002703. Epub 2013 Oct 8.
Other Identifiers
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Pro00007128
Identifier Type: -
Identifier Source: org_study_id
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