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Lidocaine For Neuroprotection During Cardiac Surgery

NCT00938964 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 550

Last updated 2019-05-10

Study results available
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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.

Conditions

Interventions

DRUG

Lidocaine

Lidocaine versus placebo infusion for 48 hours

DRUG

Placebo

Lidocaine versus placebo infusion for 48 hours

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • CAS Medical Systems, Inc.

    collaborator INDUSTRY

  • Duke University

    lead OTHER

Principal Investigators

  • Joseph P Mathew, M. D. · Duke University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2016-07-18
Completion
2017-05-23

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00938964 on ClinicalTrials.gov