Overview

This trial is active, not recruiting.

Condition cognitive decline
Treatments lidocaine, placebo
Sponsor Duke University
Collaborator National Heart, Lung, and Blood Institute (NHLBI)
Start date July 2009
End date August 2016
Trial size 476 participants
Trial identifier NCT00938964, Pro00015641, R01HL096978

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose prevention
Arm
(Experimental)
Lidocaine infusion for 48 hours
lidocaine
Lidocaine versus placebo infusion for 48 hours
(Placebo Comparator)
Normal saline infusion for 48 hours
placebo
Lidocaine versus placebo infusion for 48 hours

Primary Outcomes

Measure
Change in cognitive function from baseline
time frame: 6 weeks after surgery

Secondary Outcomes

Measure
Platelet and white blood cell activation gradients
time frame: Intraoperative
Change in quality of Life, as measured by questionnaires
time frame: baseline, 6-weeks, and 1-year
Change in neurological function, as measured by neurological assessment scores
time frame: baseline, 6-weeks, and 1-year
Change in cognitive function from baseline
time frame: 1 year after surgery

Eligibility Criteria

Male or female participants at least 50 years old.

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 -

Additional Information

Official title Lidocaine For Neuroprotection During Cardiac Surgery
Principal investigator Joseph P Mathew, M. D.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Duke University.