Lidocaine For Neuroprotection During Cardiac Surgery

This study is currently recruiting participants.
Verified December 2013 by Duke University
Sponsor:
Collaborators:
CAS Medical Systems, Inc.
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00938964
First received: July 10, 2009
Last updated: December 26, 2013
Last verified: December 2013

July 10, 2009
December 26, 2013
July 2009
July 2014   (final data collection date for primary outcome measure)
Change in cognitive function from baseline [ Time Frame: 6 weeks after surgery ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00938964 on ClinicalTrials.gov Archive Site
Platelet and white blood cell activation gradients [ Time Frame: Intraoperative ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Lidocaine For Neuroprotection During Cardiac Surgery
Lidocaine For Neuroprotection During Cardiac Surgery

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Cognitive Decline
  • Drug: Lidocaine
    Lidocaine versus placebo infusion for 48 hours
  • Drug: Placebo
    Lidocaine versus placebo infusion for 48 hours
  • Experimental: Lidocaine
    Lidocaine infusion for 48 hours
    Intervention: Drug: Lidocaine
  • Placebo Comparator: Placebo
    Normal saline infusion for 48 hours
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
476
July 2014
July 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. CABG, CABG + Valve, or Valve surgery
  2. Use of cardiopulmonary bypass

Exclusion Criteria:

  1. Less than 50 years of age
  2. History of diabetes
  3. History of symptomatic cerebrovascular disease (e.g. prior stroke) with residual deficit
  4. Alcoholism (> 2 drinks/day)
  5. History of psychiatric illness (any clinical diagnoses requiring therapy)
  6. History of drug abuse (any illicit drug use in the past 3 months)
  7. Hepatic insufficiency (liver function tests > 1.5 times the upper limit of normal)
  8. Severe pulmonary insufficiency (requiring home oxygen therapy)
  9. Renal failure (baseline serum creatinine > 2.0 mg/dl)
  10. Pregnant women
  11. Unable to read and thus unable to complete the cognitive testing
  12. 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 -
Both
50 Years and older
No
Contact: Joseph P Mathew, M. D. 919-681-6752 mathe014@mc.duke.edu
United States
 
NCT00938964
Pro00015641, R01HL096978
Yes
Duke University
Duke University
  • National Institutes of Health (NIH)
  • CAS Medical Systems, Inc.
Principal Investigator: Joseph P Mathew, M. D. Duke University
Duke University
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP