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
  Purpose

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.


Condition Intervention
Cognitive Decline
Drug: Lidocaine
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Lidocaine For Neuroprotection During Cardiac Surgery

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Change in cognitive function from baseline [ Time Frame: 6 weeks after surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Platelet and white blood cell activation gradients [ Time Frame: Intraoperative ] [ Designated as safety issue: No ]

Estimated Enrollment: 476
Study Start Date: July 2009
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lidocaine
Lidocaine infusion for 48 hours
Drug: Lidocaine
Lidocaine versus placebo infusion for 48 hours
Placebo Comparator: Placebo
Normal saline infusion for 48 hours
Drug: Placebo
Lidocaine versus placebo infusion for 48 hours

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 -
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00938964

Contacts
Contact: Joseph P Mathew, M. D. 919-681-6752 mathe014@mc.duke.edu

Locations
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Joseph P Mathew, M.D.    919-681-9698    mathe014@mc.duke.edu   
United States, Virginia
Sentara Cardiovascular Research Institute Recruiting
Norfolk, Virginia, United States, 23507
Contact: David Schinderle, M. D.    757-620-3609    d-schinderle@cox.net   
Principal Investigator: David Schinderle, M. D.         
Sponsors and Collaborators
Duke University
CAS Medical Systems, Inc.
Investigators
Principal Investigator: Joseph P Mathew, M. D. Duke University
  More Information

Publications:
Reitan RM. Validity of the trail making test as an indicator of organic brain damage. Percept Mot Skills, 1958; 8:271-276
Mark DB, Nelson C, Delong E, et al. Comparisin of quality of life outcomes following coronary angioplasty, coronary bypass surgery and medicine. J Am Coll Cardiol. 1993; 21:216A
McDowell I, Newell C. Measuring Health: A Guide To Rating Scales And Questionnaires. New York: Oxford University Press; 1987.
Benjamini Y, Hochberg Y. Controlling the False Discovery Rate: A Practical and Powerful Approach to Multiple Testing. J R Statist Soc B. 1995;57(1):289-300

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00938964     History of Changes
Other Study ID Numbers: Pro00015641, R01HL096978
Study First Received: July 10, 2009
Last Updated: December 26, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
Cognition

Additional relevant MeSH terms:
Cognition Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on April 16, 2014