Effects of Magnesium on Individuals Undergoing Coronary Artery Bypass Graft Surgery

NCT00041392 | Completed Phase 2 Results

• 2 other identifiers: Pro00007128R01HL069081
• Study Type: interventional
• Target: 389
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Disease; Heart Diseases; Cardiovascular Diseases; Neurologic Manifestations

Outcome Measures

Primary Outcomes (1)

• Cognitive Function

  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.

  Measured at baseline and 6 weeks

Study Arms (2)

Magnesium

ACTIVE COMPARATOR

100 mg/kg magnesium

Drug: Magnesium

0.9 % saline

PLACEBO COMPARATOR

100 mg/kg 0.9 % saline

Drug: 0.9% saline

Interventions

Magnesium DRUG

100 mg/kg

Magnesium

0.9% saline DRUG

Placebo

0.9 % saline

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Coronary heart disease

You may not qualify if:

• Early dementia
• History of psychiatric illness

Sponsors & Collaborators

• Duke University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Related Publications (1)

• 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.

  PMID: 24105697 DERIVED

MeSH Terms

Conditions

Coronary Disease; Heart Diseases; Cardiovascular Diseases; Neurologic Manifestations

Interventions

Magnesium; Saline Solution

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Vascular Diseases; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Metals, Alkaline Earth; Elements; Inorganic Chemicals; Metals, Light; Metals; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Dr. Mark F. Newman
• Organization: Duke University

newma005@mc.duke.edu

919-681-6646

Study Officials

• Mark F. Newman, MD

  Duke University

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2002
• First Posted: July 9, 2002
• Study Start: December 1, 2001
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: July 30, 2013
• Results First Posted: October 30, 2012

Record last verified: 2012-04

Locations

US (1)