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The Study of Post-operation Delirium and Prognosis of Cardiac Surgery Patients

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ClinicalTrials.gov Identifier: NCT03351985
Recruitment Status : Unknown
Verified November 2017 by Jingyuan,Xu, Southeast University, China.
Recruitment status was:  Not yet recruiting
First Posted : November 24, 2017
Last Update Posted : November 24, 2017
Sponsor:
Information provided by (Responsible Party):
Jingyuan,Xu, Southeast University, China

Study Description
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Brief Summary:
Delirium is the most common neurological complication of cardiac surgery patients and associated with poor prognosis. In recent years, the important role of quantitative electroencephalogram (qEEG) in brain function monitoring is becoming increasingly prominent. The purpose of this study is to evaluate the effect of qEEG in predictive of post-operation delirium and prognosis of cardiac surgery patients.

Condition or disease Intervention/treatment
Delirium Device: quantitative electroencephalogram (qEEG)

Study Design
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Study Type : Observational
Estimated Enrollment : 56 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: the Effect of Quantitative Electroencephalogram (qEEG) in Predictive of Post-operation Delirium and Prognosis of Cardiac Surgery Patients
Estimated Study Start Date : December 1, 2017
Estimated Primary Completion Date : June 30, 2018
Estimated Study Completion Date : August 31, 2018

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Delirium Group
The cardiac surgery patients with delirium receive the quantitative electroencephalogram (qEEG) monitoring within 1 hour when they admitted to ICU
 Device: quantitative electroencephalogram (qEEG)
the patients receive the quantitative electroencephalogram (qEEG) monitoring within 1 hour when they admitted to ICU
Non-delirium Group
The cardiac surgery patients without delirium receive the quantitative electroencephalogram (qEEG) monitoring within 1 hour when they admitted to ICU
 Device: quantitative electroencephalogram (qEEG)
the patients receive the quantitative electroencephalogram (qEEG) monitoring within 1 hour when they admitted to ICU


Outcome Measures
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Primary Outcome Measures :
  1. amplitude integrated electroencephalogram (aEEG) [ Time Frame: 24 hours ]
    the electroencephalogram amplitude of cardiac surgery patients assessed by quantitative electroencephalogram when admitted to intensive care unit


Secondary Outcome Measures :
  1. alpha frequency band energy [ Time Frame: 24 hours ]
    the percentage of alpha frequency band of cardiac surgery patients assessed by quantitative electroencephalogram when admitted to intensive care unit

  2. beta frequency band energy [ Time Frame: 24 hours ]
    the percentage of beta frequency band of cardiac surgery patients assessed by quantitative electroencephalogram when admitted to intensive care unit

  3. theta frequency band energy [ Time Frame: 24 hours ]
    the percentage of theta frequency band of cardiac surgery patients assessed by quantitative electroencephalogram when admitted to intensive care unit

  4. delta frequency band energy [ Time Frame: 24 hours ]
    the percentage of delta frequency band of cardiac surgery patients assessed by quantitative electroencephalogram when admitted to intensive care unit

  5. alpha variability [ Time Frame: 24 hours ]
    the variability of alpha frequency band of cardiac surgery patients assessed by quantitative electroencephalogram when admitted to intensive care unit

  6. arterial oxygen saturation (SaO2) [ Time Frame: 24 hours ]
    the level of arterial oxygen saturation (SaO2) of cardiac surgery patients when admitted to intensive care unit

  7. central venous oxygen saturation (ScvO2) [ Time Frame: 24 hours ]
    the level of central venous oxygen saturation(ScvO2) of cardiac surgery patients when admitted to intensive care unit

  8. neuron specific enolase (NSE) [ Time Frame: 24 hours ]
    the level of neuron specific enolase (NSE) of cardiac surgery patients when admitted to intensive care unit

  9. interleukin-6 (IL-6) [ Time Frame: 24 hours ]
    the level of interleukin-6 (IL-6) of cardiac surgery patients when admitted to intensive care unit

  10. troponin i (TNI) [ Time Frame: 24 hours ]
    the level of troponin i (TNI) of cardiac surgery patients when admitted to intensive care unit

  11. high-sensitivity C-reactive protein (hs-CRP) [ Time Frame: 24 hours ]
    the level of high-sensitivity C-reactive protein (hs-CRP) of cardiac surgery patients when admitted to intensive care unit

  12. N-terminal pro brain natriuretic peptide (NT-pro-BNP) [ Time Frame: 24 hours ]
    the level of N-terminal pro brain natriuretic peptide (NT-pro-BNP) of cardiac surgery patients when admitted to intensive care unit


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Adult patients receiving cardiac surgery
Criteria

Inclusion Criteria:

  1. The patients of cardiac surgery aged ≥18 years
  2. Signed informed consent

Exclusion Criteria:

  1. Patients with a history of any neurologic and psychiatric disease
  2. Cognitive disorder
  3. Stroke history in three years
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03351985


Contacts
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Contact: Liu Wenxue, master 15751866806 diligent_hi@163.com
Contact: Yang Congshan, professor 13851462550 ycs7415@163.com

Sponsors and Collaborators
Southeast University, China
Investigators
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Principal Investigator: Liu Wenxue, master Southeast University
More Information
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Responsible Party: Jingyuan,Xu, professor, Southeast University, China
ClinicalTrials.gov Identifier: NCT03351985    
Other Study ID Numbers: 2017ZDSYLL054-P01
First Posted: November 24, 2017    Key Record Dates
Last Update Posted: November 24, 2017
Last Verified: November 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
 Nervous System Diseases
Neurocognitive Disorders
Mental Disorders