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CompletedNCT05448534Updated Feb 28, 2023

Electroencephalographic Patterns of Septic Patients and Its Correlation With Cognitive Outcomes

An observational study in Sepsis, sponsored by Hospital Sao Domingos. Completed at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-02-28.

Sponsored by Hospital Sao Domingos · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
160
Ages
18 Years and older
Sex
All
01

Study 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..

Read the 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.

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Conditions studied

  • Sepsis

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Keywords

  • Eletroencephalography
  • Sepsis
  • Septic shock
  • Critical care
  • cognitive dysfunction
  • Montreal cognitive assessment
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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

All critically ill patients with sepsis and septic shock expected to stay in the intensive care unit (ICU) for at least 4 days admitted to 3 medical ICUs and 2 surgical ICUs of a tertiary hospital in Brazil.

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.

Exclusion criteria

-

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

Observational model
Cohort
Time perspective
Prospective
Enrollment
160 participants (actual)
Patient registry
No

Interventions

  • Diagnostic testEletroencephalography

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

    Also known as: Montreal Cognitive Assessment (MoCA), Sinek and young scales

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What researchers measure

Primary outcomes

  1. Electroencephalographic patterns

    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.

    Time frame: 3 months after hospital discharge

  2. Cognitive evaluation

    Cognitive dysfunction measured by Montreal Cognitive Assessment (MoCA)

    Time frame: 3 months after hospital discharge

Secondary outcomes

  1. electroencephalographic patterns and 28 days mortality .

    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.

    Time frame: 28 days

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

    Time frame: 3 months after hospital discharge

06

Study locations

1 site
  • Icu Hospital Sao Domingos
    Sao Luis, Maranhão 65060-645, Brazil
07

References and documents

Publications

  • Azabou E, Magalhaes E, Braconnier A, Yahiaoui L, Moneger G, Heming N, Annane D, Mantz J, Chretien F, Durand MC, Lofaso F, Porcher R, Sharshar T; Groupe d'Explorations Neurologiques en Reanimation (GENER). Early Standard Electroencephalogram Abnormalities Predict Mortality in Septic Intensive Care Unit Patients. PLoS One. 2015 Oct 8;10(10):e0139969. doi: 10.1371/journal.pone.0139969. eCollection 2015. PubMed 26447697 ↗
  • Eidelman LA, Putterman D, Putterman C, Sprung CL. The spectrum of septic encephalopathy. Definitions, etiologies, and mortalities. JAMA. 1996 Feb 14;275(6):470-3. PubMed 8627969 ↗
  • Iwashyna TJ, Ely EW, Smith DM, Langa KM. Long-term cognitive impairment and functional disability among survivors of severe sepsis. JAMA. 2010 Oct 27;304(16):1787-94. doi: 10.1001/jama.2010.1553. PubMed 20978258 ↗
  • Oddo M, Carrera E, Claassen J, Mayer SA, Hirsch LJ. Continuous electroencephalography in the medical intensive care unit. Crit Care Med. 2009 Jun;37(6):2051-6. doi: 10.1097/CCM.0b013e3181a00604. PubMed 19384197 ↗
  • Young GB, Bolton CF, Archibald YM, Austin TW, Wells GA. The electroencephalogram in sepsis-associated encephalopathy. J Clin Neurophysiol. 1992 Jan;9(1):145-52. doi: 10.1097/00004691-199201000-00016. PubMed 1552002 ↗
  • Hosokawa K, Gaspard N, Su F, Oddo M, Vincent JL, Taccone FS. Clinical neurophysiological assessment of sepsis-associated brain dysfunction: a systematic review. Crit Care. 2014 Dec 8;18(6):674. doi: 10.1186/s13054-014-0674-y. PubMed 25482125 ↗

Individual participant data

Plan to share: No

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Registry details

Key details

Study ID
NCT05448534
Lead sponsor
Hospital Sao Domingos
Responsible party
José Raimundo Araujo de Azevedo (ICU Coordinator, Hospital Sao Domingos) — Principal investigator
First posted
Jul 7, 2022
Start date
Nov 1, 2021
Primary completion
Nov 30, 2022
Completion
Feb 24, 2023
Last update
Feb 28, 2023

Study contacts

JOSE AZEVEDO, MD, PhD
study director · Hospital Sao Domingos

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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