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The Dynamic Change of MMN in Patients With Sepsis Associated Encephalopathy

NCT04870983 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 84

Last updated 2021-05-04

No results posted yet for this study

Summary

Sepsis-associated encephalopathy (SAE), is one of the most common organ dysfunction during the acute phase in sepsis and septic shock. Electroencephalogram (EEG) and auditory evoked potentials (AEPs), which reflect different aspects of brain function, are the most commonly used neurophysiological indices to detect acute brain dysfunction in critically ill patients including sepsis and septic shock. AEPs show the systemic responsiveness of the central nervous to auditory stimuli, so they can be considered a direct measure of brain responsiveness. Mismatch negativity (MMN) is a change-specific component of ERPs, which elicited by a deviant stimulus occurring in a sequence of repetitive stimuli. This component is thought to represent the automatic and unconscious detection of acoustic changes which requires good perceptual discriminative capacity and iconic memory. The peaks of MMN appear at 100 \~ 250 ms from deviant stimulus onset; with increasing magnitude of stimulus change, the peak latency of MMN was shortened and the amplitude increased. Since MMN can be elicited even in the absence of attention, subjects do not need to actively participate. The MMN has been extensively demonstrated to be used in the prediction of awakening in comatose patients for various reasons, and also has been reported to predict awakening in deeply sedated critically ill patients recently. However, it remains unclear whether SAE affects MMN in amplitude and latency that reflects cognitive processing of the auditory information.

Patients with sepsis and septic shock who met the inclusion criteria were screened daily on the CAM-ICU scale, and those with positive CAM-ICU were diagnosed with SAE.All patients were tested for event-evoked potentials on Day 1 and Day 3 after inclusion and were followed up to Day 28 after discharge. The investigators intend to observe the dynamic change of MMN amplitude and latency between SAE and non-SAE groups. Logic regression analysis was used to determine whether the change of MMN was a predictor of SAE.

Conditions

  • Sepsis-Associated Encephalopathy
  • Mismatch Negativity

Sponsors & Collaborators

  • Chinese Medical Association

    lead NETWORK

Principal Investigators

  • Wenkui Yu, M.D. · The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-01
Primary Completion
2022-02-01
Completion
2022-02-01

Countries

  • China

Study Locations

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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 NCT04870983 on ClinicalTrials.gov