Status:
COMPLETED
Lidocaine For Neuroprotection During Cardiac Surgery
Lead Sponsor:
Duke University
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
CAS Medical Systems, Inc.
Conditions:
Cognitive Decline
Eligibility:
All Genders
50+ years
Phase:
NA
Brief Summary
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 f...
Eligibility Criteria
Inclusion
- CABG, CABG + Valve, or Valve surgery
- Use of cardiopulmonary bypass
Exclusion
- 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 -
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 23 2017
Estimated Enrollment :
550 Patients enrolled
Trial Details
Trial ID
NCT00938964
Start Date
July 1 2009
End Date
May 23 2017
Last Update
May 10 2019
Active Locations (2)
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1
Duke University Medical Center
Durham, North Carolina, United States, 27710
2
Sentara Cardiovascular Research Institute
Norfolk, Virginia, United States, 23507