Electroencephalographic Patterns of Septic Patients and Its Correlation With Cognitive Outcomes

Completed

• Conditions: Sepsis

• Registration Number: NCT05448534
• Lead Sponsor: Hospital Sao Domingos

Brief Summary

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..

Detailed Description

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.

Study Timeline

• Study Start: 2021-11-01
• Study First Submitted: 2022-06-29
• Study First Submitted QC: 2022-07-02
• Study First Posted: 2022-07-07
• Primary Completion: 2022-11-30
• Status Verified: 2023-02
• Study Completion: 2023-02-24
• Last Update Submitted: 2023-02-27
• Last Update Posted: 2023-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Electroencephalographic patterns	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.
Cognitive evaluation	3 months after hospital discharge	Cognitive dysfunction measured by Montreal Cognitive Assessment (MoCA)

Secondary Outcome Measures

Name	Time	Method
electroencephalographic patterns and 28 days mortality .	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.
Quality of Life (SF-36) after 3 months of discharge	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.

Trial Locations

Locations (1)

Icu Hospital Sao Domingos; 🇧🇷 Sao Luis, Maranhão, Brazil