Trial · NCT00938964
Lidocaine For Neuroprotection During Cardiac Surgery
NCT00938964, Not applicable, Completed, Duke University; results first posted 2017-08-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Lidocaine For Neuroprotection During Cardiac Surgery. Trials, record NCT00938964. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00938964
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Lidocaine For Neuroprotection During Cardiac Surgery
- NCT number
- NCT00938964
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 550 participants, actual
- Lead sponsor
- Duke University
- Conditions
- Cognitive Decline
- Interventions
- Lidocaine, Placebo
- First posted
- 2009-07-14
- Last updated
- 2019-05-10
- Results first posted
- 2017-08-24
Source ClinicalTrials.gov
Registered outcomes29
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Cognitive Function From Baseline Characterized as Continuous Cognitive Change | 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. |
| Primary | 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 | 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. |
| Secondary | Transcerebral Activation Gradients of Platelets | 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 |
| Secondary | Transcerebral Activation Gradients of Neutrophils | 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 |
| Secondary | Transcerebral Activation Gradients of Monocytes | 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 |
| Secondary | Transcerebral Activation Gradient of Platelet-neutrophil Conjugates | 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 |
| Secondary | Change in Cognitive Function From Baseline | 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 |
| Secondary | Change in Duke Activity Status Index (DASI) | 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. |
| Secondary | Change in Duke Activity Status Index (DASI) | 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. |
| Secondary | Change in Neurological Function, as Measured by the National Institutes of Health Stroke Scale (NIHSS) | 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). |
1 to 10 of 29Source ClinicalTrials.gov
See all 29 registered outcomesOutcomes29
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Cognitive Function From Baseline Characterized as Continuous Cognitive Change | Preoperative to 6 weeks after surgery | units on a scale | MEAN | |
| PRIMARY | 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 | Preoperative to 6 weeks after surgery | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Transcerebral Activation Gradients of Platelets | Baseline to 6 hours post cross-clamp removal | Planned substudy, that was analyzed after 202 enrolled subjects | Mean linear fluorescence intensity-MLFI | MEAN |
| SECONDARY | Transcerebral Activation Gradients of Neutrophils | Baseline to 6 hours post cross-clamp removal | Planned substudy, that was analyzed after 202 enrolled subjects | Mean linear fluorescence intensity-MLFI | MEAN |
| SECONDARY | Transcerebral Activation Gradients of Monocytes | Baseline to 6 hours post cross-clamp removal | Planned substudy, that was analyzed after 202 enrolled subjects. | Mean linear fluorescence intensity-MLFI | MEAN |
| SECONDARY | Transcerebral Activation Gradient of Platelet-neutrophil Conjugates | Baseline to 6 hours post cross-clamp removal | Planned substudy, that was analyzed after 202 enrolled subjects. | Mean linear fluorescence intensity-MLFI | MEAN |
| SECONDARY | Change in Cognitive Function From Baseline | 1 year after surgery | There was 26 lidocaine patients and 17 placebo patients lost to follow-up between the primary 6-week follow-up and the final 1-year follow-up time point. Only those returning for 1 year follow-up were included in the analysis. | units on a scale | MEAN |
| SECONDARY | Change in Duke Activity Status Index (DASI) | baseline, 6-weeks | units on a scale | MEAN | |
| SECONDARY | Change in Duke Activity Status Index (DASI) | baseline, 1-year | There was 26 lidocaine patients and 17 placebo patients lost to follow-up between the primary 6-week follow-up and the final 1-year follow-up time point. Only those returning for 1 year follow-up were included in the analysis. | units on a scale | MEAN |
| SECONDARY | Change in Neurological Function, as Measured by the National Institutes of Health Stroke Scale (NIHSS) | baseline, 6-weeks | units on a scale | MEAN |
1 to 10 of 29Source ClinicalTrials.gov
See all 29 outcomesResults by group86
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Cognitive Function From Baseline Characterized as Continuous Cognitive Change | Lidocaine | 0.07 | Standard Deviation 0.32 | units on a scale | |
| Change in Cognitive Function From Baseline Characterized as Continuous Cognitive Change | Placebo | 0.07 | Standard Deviation 0.37 | units on a scale | |
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 | Lidocaine | 87 | Participants | ||
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 | Placebo | 83 | Participants | ||
| Transcerebral Activation Gradients of Platelets | Lidocaine | Baseline | -0.03 | Standard Deviation 0.79 | Mean linear fluorescence intensity-MLFI |
| Transcerebral Activation Gradients of Platelets | Placebo | Baseline | 0.35 | Standard Deviation 1.91 | Mean linear fluorescence intensity-MLFI |
| Transcerebral Activation Gradients of Platelets | Lidocaine | Cross-clamp removal | 0.03 | Standard Deviation 1.21 | Mean linear fluorescence intensity-MLFI |
| Transcerebral Activation Gradients of Platelets | Placebo | Cross-clamp removal | 0.43 | Standard Deviation 1.44 | Mean linear fluorescence intensity-MLFI |
| Transcerebral Activation Gradients of Platelets | Lidocaine | End of Bypass | 0.33 | Standard Deviation 3.25 | Mean linear fluorescence intensity-MLFI |
| Transcerebral Activation Gradients of Platelets | Placebo | End of Bypass | 0.05 | Standard Deviation 2.65 | Mean linear fluorescence intensity-MLFI |
1 to 10 of 86Source ClinicalTrials.gov
See all 86 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Lidocaine | 241 | |
| Overall Study | STARTED | Placebo | 237 | |
| Overall Study | COMPLETED | Lidocaine | 211 | |
| Overall Study | COMPLETED | Placebo | 209 | |
| Overall Study | NOT COMPLETED | Lidocaine | 30 | |
| Overall Study | NOT COMPLETED | Placebo | 28 |
Source ClinicalTrials.gov
Adverse events192
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Atrial Dysrhythmia - Atrial Fibrillation | Cardiac disorders | Lidocaine | 34 | 241 | 34 |
| other | Atrial Dysrhythmia - Atrial Fibrillation | Cardiac disorders | Placebo | 34 | 237 | 34 |
| serious | Acute Blood Loss anemia | Blood and lymphatic system disorders | Lidocaine | 4 | 241 | 4 |
| serious | Acute Blood Loss anemia | Blood and lymphatic system disorders | Placebo | 3 | 237 | 3 |
| serious | Acute Urinary Retention | Renal and urinary disorders | Lidocaine | 0 | 241 | 0 |
| serious | Acute Urinary Retention | Renal and urinary disorders | Placebo | 1 | 237 | 1 |
| serious | Acute Kidney Injury | Renal and urinary disorders | Lidocaine | 2 | 241 | 2 |
| serious | Acute Kidney Injury | Renal and urinary disorders | Placebo | 6 | 237 | 6 |
| serious | Anaphylatic or Anaphylactoid rxn | Immune system disorders | Lidocaine | 1 | 241 | 1 |
| serious | Anaphylatic or Anaphylactoid rxn | Immune system disorders | Placebo | 0 | 237 | 0 |
1 to 10 of 192Source ClinicalTrials.gov
See all 192 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Lidocaine | 6 | 241 |
| Total, all-cause mortality | Placebo | 7 | 237 |
| Total, other adverse events | Lidocaine | 34 | 241 |
| Total, other adverse events | Placebo | 34 | 237 |
| Total, serious adverse events | Lidocaine | 105 | 241 |
| Total, serious adverse events | Placebo | 103 | 237 |
Source ClinicalTrials.gov
Papers38
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01HL096978 | Lidocaine for Neuroprotection During Cardiac Surgery | MATHEW, JOSEPH P | DUKE UNIVERSITY | NATIONAL HEART, LUNG, AND BLOOD INSTITUTE | 2009 to 2013 |
Source NIH RePORTER
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
Lidocaine vs Placebo: 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 | Trial comparisons |
| Lidocaine vs Placebo: deaths from any cause | Trial comparisons |
| Lidocaine vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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