Lidocaine For Neuroprotection During Cardiac Surgery

Completed · Not applicable · Has a placebo group

Conditions studied: Cognitive Decline

In brief

The purpose of this study is to see if a drug called lidocaine prevents cognitive injury (a decline in mental abilities) after heart surgery. Lidocaine is currently FDA approved and is commonly used for treating some heart rhythm disorders and for regional anesthesia (blocking nerves). The investigators are enrolling subjects in this research project to see if lidocaine will reduce the high incidence of cognitive injury seen after heart surgery. As part of this study, the investigators will also evaluate the relationship between cognitive injury and genetic makeup and the chemical changes in the subjects blood during and after surgery.

Key facts

Study ID

NCT00938964

Run by

Duke University

People needed

550

Starts

2009-07-01

Expected to finish

2017-05-23

Last updated by the study team

2019-05-10

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• CABG, CABG + Valve, or Valve surgery
• Use of cardiopulmonary bypass

You may not qualify if…

• Less than 50 years of age
• History of diabetes
• History of symptomatic cerebrovascular disease (e.g. prior stroke) with residual deficit
• Alcoholism (> 2 drinks/day)
• History of psychiatric illness (any clinical diagnoses requiring therapy)
• History of drug abuse (any illicit drug use in the past 3 months)
• Hepatic insufficiency (liver function tests > 1.5 times the upper limit of normal)
• Severe pulmonary insufficiency (requiring home oxygen therapy)
• Renal failure (baseline serum creatinine > 2.0 mg/dl)
• Pregnant women
• Unable to read and thus unable to complete the cognitive testing
• Score < 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 -

Where it is running

• Duke University Medical Center — Durham, North Carolina, United States
• Sentara Cardiovascular Research Institute — Norfolk, Virginia, United States

Full record on ClinicalTrials.gov

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