N/A
N=478
Lidocaine For Neuroprotection During Cardiac Surgery
Cognitive Decline
Bottom Line
View on ClinicalTrials.gov: NCT00938964 ↗Enrolled (actual)
478
Serious AEs
43.5%
Results posted
Aug 2017
Primary outcome: Primary: Change in Cognitive Function From Baseline Characterized as Continuous Cognitive Change — 0.07; 0.07 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Lidocaine (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Duke University
- Primary completion
- Jul 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Cognitive Function From Baseline Characterized as Continuous Cognitive Change |
0.07; 0.07 | — |
| 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 |
87; 83 | — |
| SECONDARY Transcerebral Activation Gradients of Platelets |
-0.03; 0.35; 0.03; 0.43; 0.33; 0.05 | — |
| SECONDARY Transcerebral Activation Gradients of Neutrophils |
-2.02; -0.08; 0.56; 0.17; 0.58; 1.19 | — |
| SECONDARY Transcerebral Activation Gradients of Monocytes |
-4.22; -0.04; -2.46; 1.83; -0.34; 2.64 | — |
| SECONDARY Transcerebral Activation Gradient of Platelet-neutrophil Conjugates |
-0.15; -0.43; 0.02; -0.73; -0.73; -0.40 | — |
| SECONDARY Change in Cognitive Function From Baseline |
0.09; 0.07 | — |
| SECONDARY Change in Duke Activity Status Index (DASI) |
6.3; 6.96 | — |
| SECONDARY Change in Duke Activity Status Index (DASI) |
6.3; 6.96 | — |
| SECONDARY Change in Neurological Function, as Measured by the National Institutes of Health Stroke Scale (NIHSS) |
0.05; 0.07 | — |
| SECONDARY Change in Neurological Function, as Measured by the National Institutes of Health Stroke Scale (NIHSS) |
0.05; 0.07 | — |
| SECONDARY Change in Center for Epidemiological Studies Depression Scale (CES-D) |
-1.27; -0.89 | — |
| SECONDARY Change in Center for Epidemiological Studies Depression Scale (CES-D) |
-1.27; -0.89 | — |
| SECONDARY Change in Spielberger State Anxiety Inventory (STAI) |
-6.70; -6.39 | — |
| SECONDARY Change in Spielberger State Anxiety Inventory (STAI) |
-6.70; -6.39 | — |
| SECONDARY Change in Symptom Limitations |
-1.39; -1.48 | — |
| SECONDARY Change in Symptom Limitations |
-1.39; -1.48 | — |
| SECONDARY Change in the Duke Older Americans Resources and Services Procedures- Instrumental Activities of Daily Living (OARS-IADL) |
-0.15; -0.31 | — |
| SECONDARY Change in the Duke Older Americans Resources and Services Procedures- Instrumental Activities of Daily Living (OARS-IADL) |
-0.15; -0.31 | — |
| SECONDARY Change in the Cognitive Difficulties Scale |
-0.46; -1.02 | — |
| SECONDARY Change in the Cognitive Difficulties Scale |
-0.46; -1.02 | — |
| SECONDARY Change in Perceived Social Support |
0.71; -1.16 | — |
| SECONDARY Change in Perceived Social Support |
0.71; -1.16 | — |
| SECONDARY Change in Social Activity |
-0.20; 0.03 | — |
| SECONDARY Change in Social Activity |
-0.20; 0.03 | — |
| SECONDARY Change in Study 36-Item Short Form Health Survey (SF-36) |
-1.37; -1.42; -0.28; -0.43 | — |
| SECONDARY Change in Study 36-Item Short Form Health Survey (SF-36) |
-1.37; -1.42; -0.28; -0.43 | — |
| SECONDARY Change in Neurological Function, as Measured by the Western Perioperative Neurologic Scale (WPNS) |
0.02; -0.02 | — |
| SECONDARY Change in Neurological Function, as Measured by the Western Perioperative Neurologic Scale (WPNS) |
0.02; -0.02 | — |
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
- 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 -
Data sourced from ClinicalTrials.gov (NCT00938964). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.