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NCT Number: NCT05448534

Electroencephalographic Patterns of Septic Patients and Its Correlation With Cognitive Outcomes

The investigators evaluated the electroencephalographic pattern by the Sinek and Young scales during ICU stay and its correlation with cognitive impairment determined by the Montreal Cognitive Assessment (MOCA) in septic patients after 3 months of ICU discharge..

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Key information

Conditions

Sepsis Cognition Disorders Cognitive Dysfunction Infections Inflammation Mental Disorders Neurocognitive Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Shock Shock, Septic Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Icu Hospital Sao Domingos

São Luís, Maranhão, 65060-645, Brazil

About this study

The investigators prospectively evaluate patients with sepsis and septic shock expected to stay in the intensive care unit (ICU) for at least 4 days. We used Sinek and Young scales to classify electroencephalographic patterns during ICU stay (in the first 24 hours after admission and in the third ICU day) and correlate with cognitive outcome evaluated with MOCA score 3 months after ICU discharge. The investigators evaluate as primary outcome the association between electroencephalographic abnormalities and cognitive dysfunction measured by the Montreal Cognitive Assessment (MoCA) 3 months after ICU discharge and secondary outcomes as association between electroencephalographic patterns and 28 days mortality, Quality of Life (SF-36) after 3 months of discharge, ventilator free days, vasoactive drug free days and Glasgow outcome scale.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Included were patients aged above 18 years, who were expected to stay in the ICU for at least 4 days, between November 2021 and November 2022.

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Exclusion criteria

  • CNS infections,
  • Structural abnormalities of the CNS, known
  • Liver or uremic encephalopathy,
  • Advanced dementia (Mini mental < 9),
  • Psychiatric disorder
  • Epilepsy.

Treatment and study plan

Eletroencephalography

Diagnostic Test

We used Sinek and Young Scale to classify electroencephalographic patterns and cognitive outcome with MOCA score.

Other names: Montreal Cognitive Assessment (MoCA), Sinek and young scales

Primary outcomes

  1. Electroencephalographic patterns

    Time frame: 3 months after hospital discharge

    Electroencephalographic patterns determined by Sinek and Young scales. The Synek outcome Scale ranges from normal (alpha dominant rhythm) to suppression (worst outcome). The scale assesses the outcome of patients with sepsis.

    Young's Scale Electroencephalographic classification of coma assesses outcome of patients with sepsis Outcome varies from normal (Delta/Theta Rhythm > 50% of record). worst result Suppression The two scales are complementary.

  2. Cognitive evaluation

    Time frame: 3 months after hospital discharge

    Cognitive dysfunction measured by Montreal Cognitive Assessment (MoCA)

Secondary outcomes

  1. electroencephalographic patterns and 28 days mortality .

    Time frame: 28 days

    Electroencephalographic patterns determined by Sinel and Young scales and 28 days .mortality. The Synek outcome Scale ranges from normal (alpha dominant rhythm) to suppression (worst outcome). The scale assesses the outcome of patients with sepsis.

    Young's Scale Electroencephalographic classification of coma assesses outcome of patients with sepsis Outcome varies from normal (Delta/Theta Rhythm > 50% of record). worst result Suppression The two scales are complementary.

  2. Quality of Life (SF-36) after 3 months of discharge

    Time frame: 3 months after hospital discharge

    Quality of life determined through Short-Form Health Survey (SF-36). Scores range from 0 to 100, 0 indicating the less favorable health status and 100 the most favorable one.

Sponsors and collaborators

Lead sponsor

Hospital Sao Domingos

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Jul 7, 2022
Registry last updated
Feb 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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