- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00938964
Lidocaine For Neuroprotection During Cardiac Surgery
May 8, 2019 updated by: Duke University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
550
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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North Carolina
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Durham, North Carolina, United States, 27710
- Duke University Medical Center
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Virginia
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Norfolk, Virginia, United States, 23507
- Sentara Cardiovascular Research Institute
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- CABG, CABG + Valve, or Valve surgery
- Use of cardiopulmonary bypass
Exclusion Criteria:
- 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 -
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Lidocaine
Lidocaine infusion for 48 hours
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Lidocaine versus placebo infusion for 48 hours
|
Placebo Comparator: Placebo
Normal saline infusion for 48 hours
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Lidocaine versus placebo infusion for 48 hours
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Cognitive Function From Baseline Characterized as Continuous Cognitive Change
Time Frame: Preoperative to 6 weeks after surgery
|
To characterize cognitive function over time, while minimizing potential redundancy in the cognitive measures, a factor analysis was performed on the 14 cognitive test scores from baseline.
We chose a five-factor solution, which represents 5 cognitive domains: structured verbal memory, unstructured verbal memory, executive function, visual memory and attention/concentration.
To quantify overall cognitive function, a baseline cognitive index was first calculated as the mean of the 5 preoperative domain scores.
The cognitive index score has a mean of zero, thus any positive score is above the mean, any negative score is below the mean.
A continuous change score was then calculated by subtracting the baseline from the 6-week cognitive index.
The resulting outcome measure is unbounded with standard deviation of 0.35.
A negative change score indicating decline and a positive score indicating improvement.
|
Preoperative to 6 weeks after surgery
|
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
Time Frame: Preoperative to 6 weeks after surgery
|
To characterize cognitive function over time, while minimizing potential redundancy in the cognitive measures, a factor analysis was performed on the 14 cognitive test scores from baseline.
We chose a five-factor solution, which represents 5 cognitive domains: structured verbal memory, unstructured verbal memory, executive function, visual memory and attention/concentration.
Each domain score is normally distributed with a mean of zero.
A change score was calculated for each domain by subtracting the baseline from the 6-week score.
A dichotomous outcome variable of post-operative cognitive deficit was defined as a decline of ≥1 standard deviation in 1 or more of the 5 domains.
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Preoperative to 6 weeks after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Transcerebral Activation Gradients of Platelets
Time Frame: Baseline to 6 hours post cross-clamp removal
|
Paired jugular venous and radial arterial blood samples were drawn at baseline, cross-clamp removal, end of cardiopulmonary bypass, and 6 hours post cross-clamp removalime points and analyzed by fluorescence-activated cell sorting to identify activated platelets.
Transcerebral activation gradients were calculated by subtracting arterial values from venous values and were compared between groups
|
Baseline to 6 hours post cross-clamp removal
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Transcerebral Activation Gradients of Neutrophils
Time Frame: Baseline to 6 hours post cross-clamp removal
|
Paired jugular venous and radial arterial blood samples were drawn at baseline, cross-clamp removal, end of cardiopulmonary bypass, and 6 hours post cross-clamp removal and analyzed by fluorescence-activated cell sorting to identify activated platelets.
Transcerebral activation gradients were calculated by subtracting arterial values from venous values and were compared between groups
|
Baseline to 6 hours post cross-clamp removal
|
Transcerebral Activation Gradients of Monocytes
Time Frame: Baseline to 6 hours post cross-clamp removal
|
Paired jugular venous and radial arterial blood samples were drawn at baseline, cross-clamp removal, end of cardiopulmonary bypass, and 6 hours post cross-clamp removalime points and analyzed by fluorescence-activated cell sorting to identify activated platelets.
Transcerebral activation gradients were calculated by subtracting arterial values from venous values and were compared between groups
|
Baseline to 6 hours post cross-clamp removal
|
Transcerebral Activation Gradient of Platelet-neutrophil Conjugates
Time Frame: Baseline to 6 hours post cross-clamp removal
|
Paired jugular venous and radial arterial blood samples were drawn at baseline, cross-clamp removal, end of cardiopulmonary bypass, and 6 hours post cross-clamp removalime points and analyzed by fluorescence-activated cell sorting to identify activated platelets.
Transcerebral activation gradients were calculated by subtracting arterial values from venous values and were compared between groups
|
Baseline to 6 hours post cross-clamp removal
|
Change in Cognitive Function From Baseline
Time Frame: 1 year after surgery
|
To characterize cognitive function over time, while minimizing potential redundancy in the cognitive measures, a factor analysis was performed on the 14 cognitive test scores from baseline.
We chose a five-factor solution, which represents 5 cognitive domains: structured verbal memory, unstructured verbal memory, executive function, visual memory and attention/concentration.
To quantify overall cognitive function, a baseline cognitive index was first calculated as the mean of the 5 preoperative domain scores.
The cognitive index score has a mean of zero, thus any positive score is above the mean, any negative score is below the mean.
A continuous change score was then calculated by subtracting the baseline from the 1 year cognitive index.
The resulting outcome measure is unbounded with standard deviation of 0.35.
A negative change score indicating decline and a positive score indicating improvement
|
1 year after surgery
|
Change in Duke Activity Status Index (DASI)
Time Frame: baseline, 6-weeks
|
The DASI is a 12-item scale of functional capacity that has been found to correlate well with objective measures of maximal exercise capacity.
Items reflect activities of personal care, ambulation, household tasks, sexual function, and recreational activities.
Activities done "with no difficulty" receive scores, which are weighted and summed, for a quantitative measure of functional status.
Scores range from 0 to 60; a higher-weighted score indicates better function.
|
baseline, 6-weeks
|
Change in Duke Activity Status Index (DASI)
Time Frame: baseline, 1-year
|
The DASI is a 12-item scale of functional capacity that has been found to correlate well with objective measures of maximal exercise capacity.
Items reflect activities of personal care, ambulation, household tasks, sexual function, and recreational activities.
Activities done "with no difficulty" receive scores, which are weighted and summed, for a quantitative measure of functional status.
Scores range from 0 to 60; a higher-weighted score indicates better function.
|
baseline, 1-year
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Change in Neurological Function, as Measured by the National Institutes of Health Stroke Scale (NIHSS)
Time Frame: baseline, 6-weeks
|
The National Institutes of Health Stroke Scale (NIHSS) is a 15-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss.
A trained observer rates the patent's ability to answer questions and perform activities.
Ratings for each item are scored with 3 to 5 grades with 0 as normal, and there is an allowance for untestable items.
The range of scores is from 0 (normal) to 42 (profound effect of stroke on patient).
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baseline, 6-weeks
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Change in Neurological Function, as Measured by the National Institutes of Health Stroke Scale (NIHSS)
Time Frame: baseline, 1-year
|
The National Institutes of Health Stroke Scale (NIHSS) is a 15-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss.
A trained observer rates the patent's ability to answer questions and perform activities.
Ratings for each item are scored with 3 to 5 grades with 0 as normal, and there is an allowance for untestable items.
The range of scores is from 0 (normal) to 42 (profound effect of stroke on patient).
|
baseline, 1-year
|
Change in Center for Epidemiological Studies Depression Scale (CES-D)
Time Frame: baseline, 6-weeks
|
Center for Epidemiological Studies Depression Scale (CES-D).
The CES-D is a 20-item self-report examination designed to measure symptoms of depression.
Subjects rate the degree to which they have experienced a range of symptoms of depression, such as "I had crying spells" and "I felt lonely."
Scores range from 0 to 60, with higher scores indicating greater depressive symptoms.
Scores greater than 16 are typically considered indicative of clinically significant depression.
|
baseline, 6-weeks
|
Change in Center for Epidemiological Studies Depression Scale (CES-D)
Time Frame: baseline, 1-year
|
Center for Epidemiological Studies Depression Scale (CES-D).
The CES-D is a 20-item self-report examination designed to measure symptoms of depression.
Subjects rate the degree to which they have experienced a range of symptoms of depression, such as "I had crying spells" and "I felt lonely."
Scores range from 0 to 60, with higher scores indicating greater depressive symptoms.
Scores greater than 16 are typically considered indicative of clinically significant depression.
|
baseline, 1-year
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Change in Spielberger State Anxiety Inventory (STAI)
Time Frame: baseline, 6-weeks
|
Spielberger State Anxiety Inventory (STAI): The STAI consists of two 20-item scales that measure anxiety.
Representative items include statements such as "I feel nervous" and "I feel worried."
These items are rated on a 4-point scale, based on how well they describe the patient's current or typical mood, from "not at all" to "very much so."
Scores range from 20 to 80, with higher scores indicating greater anxiety.
|
baseline, 6-weeks
|
Change in Spielberger State Anxiety Inventory (STAI)
Time Frame: baseline, 1-year
|
Spielberger State Anxiety Inventory (STAI): The STAI consists of two 20-item scales that measure anxiety.
Representative items include statements such as "I feel nervous" and "I feel worried."
These items are rated on a 4-point scale, based on how well they describe the patient's current or typical mood, from "not at all" to "very much so."
Scores range from 20 to 80, with higher scores indicating greater anxiety.
|
baseline, 1-year
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Change in Symptom Limitations
Time Frame: baseline, 6-weeks
|
Symptom limitations: Patients were given a list of eight symptoms and asked to rate the degree to which the symptom limited daily activities.
The symptoms were angina, shortness of breath, arthritis, back trouble, leg pains, headaches, fatigue, and other.
Scores range from 8 to 32, with higher scores indicating greater limitations.
|
baseline, 6-weeks
|
Change in Symptom Limitations
Time Frame: baseline, 1-year
|
Symptom limitations: Patients were given a list of eight symptoms and asked to rate the degree to which the symptom limited daily activities.
The symptoms were angina, shortness of breath, arthritis, back trouble, leg pains, headaches, fatigue, and other.
Scores range from 8 to 32, with higher scores indicating greater limitations.
|
baseline, 1-year
|
Change in the Duke Older Americans Resources and Services Procedures- Instrumental Activities of Daily Living (OARS-IADL)
Time Frame: baseline, 6-weeks
|
Duke Older Americans Resources and Services Procedures- Instrumental Activities of Daily Living (OARS-IADL): This measure contains six items that assess the ability to perform important tasks for daily living (e.g., "Could you prepare your own meals?"
"Could you drive a car?").
Scores range from 6 to 24.
Higher scores indicate increasing difficulty in engaging in daily activities.
|
baseline, 6-weeks
|
Change in the Duke Older Americans Resources and Services Procedures- Instrumental Activities of Daily Living (OARS-IADL)
Time Frame: baseline, 1-year
|
Duke Older Americans Resources and Services Procedures- Instrumental Activities of Daily Living (OARS-IADL): This measure contains six items that assess the ability to perform important tasks for daily living (e.g., "Could you prepare your own meals?"
"Could you drive a car?").
Scores range from 6 to 24.
Higher scores indicate increasing difficulty in engaging in daily activities.
|
baseline, 1-year
|
Change in the Cognitive Difficulties Scale
Time Frame: baseline, 6-weeks
|
Cognitive Difficulties Scale: a 39-item scale, is a self-report assessment of perceived problems in long- and short-term memory, concentration, attention, and psycho-motor coordination.
Sample items are "I forget errands I planned to do" and "I fail to recognize people I know."
Scores range from 39 to 164, with higher scores indicating greater cognitive difficulty.
|
baseline, 6-weeks
|
Change in the Cognitive Difficulties Scale
Time Frame: baseline, 1-year
|
Cognitive Difficulties Scale: a 39-item scale, is a self-report assessment of perceived problems in long- and short-term memory, concentration, attention, and psycho-motor coordination.
Sample items are "I forget errands I planned to do" and "I fail to recognize people I know."
Scores range from 39 to 164, with higher scores indicating greater cognitive difficulty.
|
baseline, 1-year
|
Change in Perceived Social Support
Time Frame: baseline, 6-weeks
|
Perceived Social Support Scale: Twelve items indicate how strongly subjects agree that there is "a special person who is around when I am in need" and "my family really tries to help me."
Choices range from "very strongly disagree" to "very strongly agree."
Items are summed for a range of 12 to 84, with a high score meaning more social support.
|
baseline, 6-weeks
|
Change in Perceived Social Support
Time Frame: baseline, 1-year
|
Perceived Social Support Scale: Twelve items indicate how strongly subjects agree that there is "a special person who is around when I am in need" and "my family really tries to help me."
Choices range from "very strongly disagree" to "very strongly agree."
Items are summed for a range of 12 to 84, with a high score meaning more social support.
|
baseline, 1-year
|
Change in Social Activity
Time Frame: baseline, 6-weeks
|
Social Activity: This measure consisted of eight items that indicate the degree of social interaction.
Sample items are "How often do you talk on the telephone with friends and relatives?"
and "How often do you attend meetings of social groups, clubs, or civic organizations?" Scores range from 8 to 32.
A lower score indicates more social activity.
|
baseline, 6-weeks
|
Change in Social Activity
Time Frame: baseline, 1-year
|
Social Activity: This measure consisted of eight items that indicate the degree of social interaction.
Sample items are "How often do you talk on the telephone with friends and relatives?"
and "How often do you attend meetings of social groups, clubs, or civic organizations?" Scores range from 8 to 32.
A lower score indicates more social activity.
|
baseline, 1-year
|
Change in Study 36-Item Short Form Health Survey (SF-36)
Time Frame: baseline, 6-weeks
|
The Medical Outcomes Study 36-Item Short Form Health Survey (SF-36): The SF-36 was designed to measure general health status.
Two scales were used: Work Activities (four items) and General Health (one item).
For the work activities scale, the reported score was the sum of four questions, each with values ranging from 1 to 4, the total score could range from 4 to 16.
A higher score on Work Activities indicates more health-related problems For the general health question, the patients ranked their health from Excellent (1) to poor (5), the scale ranged from 1 to 5 with 1 being best health and 5 being worst.
A high score in General Health indicates poorer health state.
|
baseline, 6-weeks
|
Change in Study 36-Item Short Form Health Survey (SF-36)
Time Frame: baseline, 1-year
|
The Medical Outcomes Study 36-Item Short Form Health Survey (SF-36): The SF-36 was designed to measure general health status.
Two scales were used: Work Activities (four items) and General Health (one item).
For the work activities scale, the reported score was the sum of four questions, each with values ranging from 1 to 4, the total score could range from 4 to 16.
A higher score on Work Activities indicates more health-related problems For the general health question, the patients ranked their health from Excellent (1) to poor (5), the scale ranged from 1 to 5 with 1 being best health and 5 being worst.
A high score in General Health indicates poorer health state.
|
baseline, 1-year
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Change in Neurological Function, as Measured by the Western Perioperative Neurologic Scale (WPNS)
Time Frame: baseline, 6-weeks
|
The Western perioperative neurologic scale was designed to detect neurologic deficits after cardiac surgery.
It includes 14 items classified into eight domains (mentation, speech, cranial nerve function, motor weakness, sensation and cerebellum, reflexes, and gait).
Each item is scored from 0 (severe deficit) to3 (normal), and a maximum score of 42 indicates normal neurological function.
|
baseline, 6-weeks
|
Change in Neurological Function, as Measured by the Western Perioperative Neurologic Scale (WPNS)
Time Frame: baseline, 1-year
|
The Western perioperative neurologic scale was designed to detect neurologic deficits after cardiac surgery.
It includes 14 items classified into eight domains (mentation, speech, cranial nerve function, motor weakness, sensation and cerebellum, reflexes, and gait).
Each item is scored from 0 (severe deficit) to3 (normal), and a maximum score of 42 indicates normal neurological function.
|
baseline, 1-year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Joseph P Mathew, M. D., Duke University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
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- Newman MF, Grocott HP, Mathew JP, White WD, Landolfo K, Reves JG, Laskowitz DT, Mark DB, Blumenthal JA; Neurologic Outcome Research Group and the Cardiothoracic Anesthesia Research Endeavors (CARE) Investigators of the Duke Heart Center. Report of the substudy assessing the impact of neurocognitive function on quality of life 5 years after cardiac surgery. Stroke. 2001 Dec 1;32(12):2874-81. doi: 10.1161/hs1201.099803.
- Phillips-Bute B, Mathew JP, Blumenthal JA, Grocott HP, Laskowitz DT, Jones RH, Mark DB, Newman MF. Association of neurocognitive function and quality of life 1 year after coronary artery bypass graft (CABG) surgery. Psychosom Med. 2006 May-Jun;68(3):369-75. doi: 10.1097/01.psy.0000221272.77984.e2.
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Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2009
Primary Completion (Actual)
July 18, 2016
Study Completion (Actual)
May 23, 2017
Study Registration Dates
First Submitted
July 10, 2009
First Submitted That Met QC Criteria
July 13, 2009
First Posted (Estimate)
July 14, 2009
Study Record Updates
Last Update Posted (Actual)
May 10, 2019
Last Update Submitted That Met QC Criteria
May 8, 2019
Last Verified
May 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Neurocognitive Disorders
- Cognition Disorders
- Cognitive Dysfunction
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Membrane Transport Modulators
- Anesthetics, Local
- Voltage-Gated Sodium Channel Blockers
- Sodium Channel Blockers
- Lidocaine
Other Study ID Numbers
- Pro00015641
- R01HL096978 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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