Clinical trial NCT00938964: Lidocaine For Neuroprotection During Cardiac Surgery
Official title: Lidocaine For Neuroprotection During Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Decline
Keywords: Cognition
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: CAS Medical Systems, Inc.
First posted: 2009-07-14
Enrollment: 550
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 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.


Eligibility 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 -

Primary outcomes:
measure: Change in Cognitive Function From Baseline Characterized as Continuous Cognitive Change
timeFrame: Preoperative to 6 weeks after surgery
measure: Count of Participants With a Decline of Greater Than or Equal to One Standard Deviation in One or More of Five Cognitive Domain Scores Reported as a Dichotomous Post-operative Cognitive Deficit (POCD) Outcome
timeFrame: Preoperative to 6 weeks after surgery
Secondary outcomes:
measure: Transcerebral Activation Gradients of Platelets
timeFrame: Baseline to 6 hours post cross-clamp removal
measure: Transcerebral Activation Gradients of Neutrophils
timeFrame: Baseline to 6 hours post cross-clamp removal
measure: Transcerebral Activation Gradients of Monocytes
timeFrame: Baseline to 6 hours post cross-clamp removal
measure: Transcerebral Activation Gradient of Platelet-neutrophil Conjugates
timeFrame: Baseline to 6 hours post cross-clamp removal
measure: Change in Cognitive Function From Baseline
timeFrame: 1 year after surgery
measure: Change in Duke Activity Status Index (DASI)
timeFrame: baseline, 6-weeks
measure: Change in Duke Activity Status Index (DASI)
timeFrame: baseline, 1-year
measure: Change in Neurological Function, as Measured by the National Institutes of Health Stroke Scale (NIHSS)
timeFrame: baseline, 6-weeks
measure: Change in Neurological Function, as Measured by the National Institutes of Health Stroke Scale (NIHSS)
timeFrame: baseline, 1-year
measure: Change in Center for Epidemiological Studies Depression Scale (CES-D)
timeFrame: baseline, 6-weeks
measure: Change in Center for Epidemiological Studies Depression Scale (CES-D)
timeFrame: baseline, 1-year
measure: Change in Spielberger State Anxiety Inventory (STAI)
timeFrame: baseline, 6-weeks
measure: Change in Spielberger State Anxiety Inventory (STAI)
timeFrame: baseline, 1-year
measure: Change in Symptom Limitations
timeFrame: baseline, 6-weeks
measure: Change in Symptom Limitations
timeFrame: baseline, 1-year
measure: Change in the Duke Older Americans Resources and Services Procedures- Instrumental Activities of Daily Living (OARS-IADL)
timeFrame: baseline, 6-weeks
measure: Change in the Duke Older Americans Resources and Services Procedures- Instrumental Activities of Daily Living (OARS-IADL)
timeFrame: baseline, 1-year
measure: Change in the Cognitive Difficulties Scale
timeFrame: baseline, 6-weeks
measure: Change in the Cognitive Difficulties Scale
timeFrame: baseline, 1-year
measure: Change in Perceived Social Support
timeFrame: baseline, 6-weeks
measure: Change in Perceived Social Support
timeFrame: baseline, 1-year
measure: Change in Social Activity
timeFrame: baseline, 6-weeks
measure: Change in Social Activity
timeFrame: baseline, 1-year
measure: Change in Study 36-Item Short Form Health Survey (SF-36)
timeFrame: baseline, 6-weeks
measure: Change in Study 36-Item Short Form Health Survey (SF-36)
timeFrame: baseline, 1-year
measure: Change in Neurological Function, as Measured by the Western Perioperative Neurologic Scale (WPNS)
timeFrame: baseline, 6-weeks
measure: Change in Neurological Function, as Measured by the Western Perioperative Neurologic Scale (WPNS)
timeFrame: baseline, 1-year
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Norfolk
country: United States
facility: Sentara Cardiovascular Research Institute
state: Virginia
Study officials:
affiliation: Duke University
name: Joseph P Mathew, M. D.
role: PRINCIPAL_INVESTIGATOR
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