Alzheimer's Disease Education and Referral Center

Lidocaine for Neuroprotection During Cardiac Surgery

Lidocaine for Neuroprotection During Cardiac Surgery

Overall Status: 
Recruiting
Brief Description: 

This study will assess whether the drug lidocaine, a local anesthetic, can prevent or reduce the high incidence of cognitive decline after heart surgery. Lidocaine is an FDA-approved local anesthetic that is also used to treat some heart rhythm disorders. In addition, investigators will evaluate the relationship between cognitive injury and genetic makeup and certain biochemical changes in participants during and after surgery.

Patient Qualifications: 
Min AgeMax AgeGenderHealthy Volunteers
50 Years
N/A
Both
No
Inclusion Criteria: 
    • Candidate for any of the following surgeries: coronary artery bypass graft (CABG), CABG plus valve, or valve
    • Use of cardiopulmonary bypass
Exclusion Criteria: 
    • History of diabetes
    • History of symptomatic cerebrovascular disease (for example, prior stroke) with residual deficit
    • More than two alcoholic drinks per day
    • History of psychiatric illness (any clinical diagnoses requiring therapy)
    • Any illicit drug use in the past 3 months
    • Hepatic insufficiency (liver function tests more than 1.5 times the upper limit of normal)
    • Severe pulmonary insufficiency requiring home oxygen therapy
    • Renal failure (baseline serum creatinine level of more than 2 mg/dl)
    • Pregnancy
    • Score of less than 24 on a baseline Mini Mental State examination (MMSE) or greater than or equal to 27 on the baseline Center for Epidemiological Studies Depression (CES-D) Scale
Detailed Description: 

This study will assess whether the drug lidocaine, an FDA-approved local anesthetic that works by stopping nerves from sending pain signals, can prevent or reduce the high incidence of cognitive decline after heart surgery. Lidocaine is also used to treat some heart rhythm disorders. In addition, investigators will evaluate the relationship between cognitive injury and genetic makeup and certain biochemical changes in participants during and after surgery. Participants who undergo heart surgery will receive an infusion of lidocaine or a placebo for 48 hours after surgery. Investigators will measure any change in cognitive function 6 weeks after surgery.

Locations: 
Map Marker CityStateZip CodeStatusPrimary Contact

Geolocation is 36.0038131, -78.9387241

Site
Durham
North Carolina
27710
Recruiting
Name: Joseph P Mathew, M.D.
Phone: 919-681-9698
Email: mathe014@mc.duke.edu

Geolocation is 36.8674231, -76.3145188

Site
Norfolk
Virginia
23507
Recruiting
Name: David Schinderle, M. D.
Phone: 757-620-3609
Email: d-schinderle@cox.net
Lead Sponsor: 
Agency
Duke University
Collaborator Sponsor: 
Agency
National Institutes of Health (NIH)
CAS Medical Systems, Inc.
Facility Investigators: 
NameRoleAffiliation
Joseph P. Mathew, MD
Principal Investigator
Duke University
Study Contact: 
NamePhoneEmail
Joseph P. Mathew, MD
919-681-6752
Locations
 
 
ClinicalTrials.gov ID 
NCT00938964 (follow link to view full record on ct.gov in new window)
Official Title: 
Lidocaine For Neuroprotection During Cardiac Surgery
Study Start Date: 
July 2009
Study End Date: 
July 2015
Enrollment: 
476
Trial References: