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Lidocaine For Neuroprotection During Cardiac Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00938964
First Posted: July 14, 2009
Last Update Posted: October 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
CAS Medical Systems, Inc.
Information provided by (Responsible Party):
Duke University
Results First Submitted: July 18, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Cognitive Decline
Interventions: Drug: Lidocaine
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
550 participants consented; 478 participants were randomized.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Lidocaine

Lidocaine infusion for 48 hours

Lidocaine: Lidocaine versus placebo infusion for 48 hours

Placebo

Normal saline infusion for 48 hours

Placebo: Lidocaine versus placebo infusion for 48 hours


Participant Flow:   Overall Study
    Lidocaine   Placebo
STARTED   241   237 
COMPLETED   211   209 
NOT COMPLETED   30   28 
Death                3                3 
Lost to Follow-up                2                3 
Withdrawal by Subject                22                18 
Found to Meet Exclusion Criteria                3                4 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Number of participants who completed the study are included in the baseline analysis population.

Reporting Groups
  Description
Lidocaine

Lidocaine infusion for 48 hours

Lidocaine: Lidocaine versus placebo infusion for 48 hours

Placebo

Normal saline infusion for 48 hours

Placebo: Lidocaine versus placebo infusion for 48 hours

Total Total of all reporting groups

Baseline Measures
   Lidocaine   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 211   209   420 
Age 
[Units: Years]
Mean (Standard Deviation)
 66.9  (9.1)   66.5  (9.5)   66.7  (9.3) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      60  28.4%      49  23.4%      109  26.0% 
Male      151  71.6%      160  76.6%      311  74.0% 
Region of Enrollment 
[Units: Participants]
Count of Participants
     
United States   211   209   420 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in Cognitive Function From Baseline Characterized as Continuous Cognitive Change   [ Time Frame: Preoperative to 6 weeks after surgery ]

2.  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   [ Time Frame: Preoperative to 6 weeks after surgery ]

3.  Secondary:   Transcerebral Activation Gradients of Platelets   [ Time Frame: Baseline to 6 hours post cross-clamp removal ]

4.  Secondary:   Transcerebral Activation Gradients of Neutrophils   [ Time Frame: Baseline to 6 hours post cross-clamp removal ]

5.  Secondary:   Transcerebral Activation Gradients of Monocytes   [ Time Frame: Baseline to 6 hours post cross-clamp removal ]

6.  Secondary:   Transcerebral Activation Gradient of Platelet-neutrophil Conjugates   [ Time Frame: Baseline to 6 hours post cross-clamp removal ]

7.  Secondary:   Change in Duke Activity Status Index (DASI)   [ Time Frame: baseline, 6-weeks ]

8.  Secondary:   Change in Neurological Function, as Measured by the National Institutes of Health Stroke Scale (NIHSS)   [ Time Frame: baseline, 6-weeks ]

9.  Secondary:   Change in Center for Epidemiological Studies Depression Scale (CES-D)   [ Time Frame: baseline, 6-weeks ]

10.  Secondary:   Change in Spielberger State Anxiety Inventory (STAI)   [ Time Frame: baseline, 6-weeks ]

11.  Secondary:   Change in Symptom Limitations   [ Time Frame: baseline, 6-weeks ]

12.  Secondary:   Change in the Duke Older Americans Resources and Services Procedures– Instrumental Activities of Daily Living (OARS-IADL)   [ Time Frame: baseline, 6-weeks ]

13.  Secondary:   Change in the Cognitive Difficulties Scale   [ Time Frame: baseline, 6-weeks ]

14.  Secondary:   Change in Perceived Social Support   [ Time Frame: baseline, 6-weeks ]

15.  Secondary:   Change in Social Activity   [ Time Frame: baseline, 6-weeks ]

16.  Secondary:   Change in Study 36-Item Short Form Health Survey (SF-36)   [ Time Frame: baseline, 6-weeks ]

17.  Secondary:   Change in Neurological Function, as Measured by the Western Perioperative Neurologic Scale (WPNS)   [ Time Frame: baseline, 6-weeks ]

18.  Secondary:   Change in Cognitive Function From Baseline   [ Time Frame: 1 year after surgery ]
Results not yet reported.   Anticipated Reporting Date:   05/2018  

19.  Secondary:   Change in Duke Activity Status Index (DASI)   [ Time Frame: baseline, 1-year ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

20.  Secondary:   Change in Neurological Function, as Measured by the National Institutes of Health Stroke Scale (NIHSS)   [ Time Frame: baseline, 1-year ]
Results not yet reported.   Anticipated Reporting Date:   05/2018  

21.  Secondary:   Change in Center for Epidemiological Studies Depression Scale (CES-D)   [ Time Frame: baseline, 1-year ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

22.  Secondary:   Change in Spielberger State Anxiety Inventory (STAI)   [ Time Frame: baseline, 1-year ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

23.  Secondary:   Change in Symptom Limitations   [ Time Frame: baseline, 1-year ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

24.  Secondary:   Change in the Duke Older Americans Resources and Services Procedures– Instrumental Activities of Daily Living (OARS-IADL)   [ Time Frame: baseline, 1-year ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

25.  Secondary:   Change in the Cognitive Difficulties Scale   [ Time Frame: baseline, 1-year ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

26.  Secondary:   Change in Perceived Social Support   [ Time Frame: baseline, 1-year ]
Results not yet reported.   Anticipated Reporting Date:   05/2018  

27.  Secondary:   Change in Social Activity   [ Time Frame: baseline, 1-year ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

28.  Secondary:   Change in Study 36-Item Short Form Health Survey (SF-36)   [ Time Frame: baseline, 1-year ]
Results not yet reported.   Anticipated Reporting Date:   05/2018  

29.  Secondary:   Change in Neurological Function, as Measured by the Western Perioperative Neurologic Scale (WPNS)   [ Time Frame: baseline, 1-year ]
Results not yet reported.   Anticipated Reporting Date:   05/2018  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Joseph Mathew, M.D
Organization: Duke University Health System
phone: 919-681-6646
e-mail: joseph.mathew@duke.edu


Publications:
Rey A. L'examen clinique en psychologie. Paper presented at : Presses Universitaires de France, 1964; Paris
Randt C, Brown E. Administration Manual: Randt Memory Test. New Youk Life Sciences Associates; 1983
Wechsler D. The Wechsler Adult Intelligence Sacle-Revised (Manual): Psychological Corporation: 1981.
Reitan RM. Validity of the trail making test as an indicator of organic brain damage. Percept Mot Skills, 1958; 8:271-276
Mark DB, Nelson C, Delong E, et al. Comparisin of quality of life outcomes following coronary angioplasty, coronary bypass surgery and medicine. J Am Coll Cardiol. 1993; 21:216A
McDowell I, Newell C. Measuring Health: A Guide To Rating Scales And Questionnaires. New York: Oxford University Press; 1987.
Cronbach LJ. Essentials of Psycological Testing. New York: Harper and Row; 1970
Benjamini Y, Hochberg Y. Controlling the False Discovery Rate: A Practical and Powerful Approach to Multiple Testing. J R Statist Soc B. 1995;57(1):289-300

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00938964     History of Changes
Other Study ID Numbers: Pro00015641
R01HL096978 ( U.S. NIH Grant/Contract )
First Submitted: July 10, 2009
First Posted: July 14, 2009
Results First Submitted: July 18, 2017
Results First Posted: August 24, 2017
Last Update Posted: October 4, 2017