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Trial · NCT00938964

Outcomes29

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYChange in Cognitive Function From Baseline Characterized as Continuous Cognitive ChangePreoperative to 6 weeks after surgeryunits on a scaleMEAN
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 surgeryParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYTranscerebral Activation Gradients of PlateletsBaseline to 6 hours post cross-clamp removalPlanned substudy, that was analyzed after 202 enrolled subjectsMean linear fluorescence intensity-MLFIMEAN
SECONDARYTranscerebral Activation Gradients of NeutrophilsBaseline to 6 hours post cross-clamp removalPlanned substudy, that was analyzed after 202 enrolled subjectsMean linear fluorescence intensity-MLFIMEAN
SECONDARYTranscerebral Activation Gradients of MonocytesBaseline to 6 hours post cross-clamp removalPlanned substudy, that was analyzed after 202 enrolled subjects.Mean linear fluorescence intensity-MLFIMEAN
SECONDARYTranscerebral Activation Gradient of Platelet-neutrophil ConjugatesBaseline to 6 hours post cross-clamp removalPlanned substudy, that was analyzed after 202 enrolled subjects.Mean linear fluorescence intensity-MLFIMEAN
SECONDARYChange in Cognitive Function From Baseline1 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 scaleMEAN
SECONDARYChange in Duke Activity Status Index (DASI)baseline, 6-weeksunits on a scaleMEAN
SECONDARYChange 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 scaleMEAN
SECONDARYChange in Neurological Function, as Measured by the National Institutes of Health Stroke Scale (NIHSS)baseline, 6-weeksunits on a scaleMEAN
SECONDARYChange in Neurological Function, as Measured by the National Institutes of Health Stroke Scale (NIHSS)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 scaleMEAN
SECONDARYChange in Center for Epidemiological Studies Depression Scale (CES-D)baseline, 6-weeksunits on a scaleMEAN
SECONDARYChange in Center for Epidemiological Studies Depression Scale (CES-D)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 scaleMEAN
SECONDARYChange in Spielberger State Anxiety Inventory (STAI)baseline, 6-weeksunits on a scaleMEAN
SECONDARYChange in Spielberger State Anxiety Inventory (STAI)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 scaleMEAN
SECONDARYChange in Symptom Limitationsbaseline, 6-weeksunits on a scaleMEAN
SECONDARYChange in Symptom Limitationsbaseline, 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 scaleMEAN
SECONDARYChange in the Duke Older Americans Resources and Services Procedures- Instrumental Activities of Daily Living (OARS-IADL)baseline, 6-weeksunits on a scaleMEAN
SECONDARYChange in the Duke Older Americans Resources and Services Procedures- Instrumental Activities of Daily Living (OARS-IADL)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 scaleMEAN
SECONDARYChange in the Cognitive Difficulties Scalebaseline, 6-weeksunits on a scaleMEAN

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

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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