Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00041392
Status:
COMPLETED
Last Update Posted:
2013-07-30
First Post:
2002-07-08
Brief Title:
Effects of Magnesium on Individuals Undergoing Coronary Artery Bypass Graft Surgery
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
PeriOperative Interventional Neuroprotection Trial POINT
Status:
COMPLETED
Status Verified Date:
2012-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
POINT
Brief Summary:
The purpose of this study is to examine the effects of supplemental magnesium on the neurocognitive function of individuals undergoing coronary artery bypass graft CABG surgery
Detailed Description:
BACKGROUND
Approximately 400000 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 mgkg 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
Approximately 400000 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 mgkg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL069081 | NIH | None | httpsreporternihgovquickSearchR01HL069081 |