Clinical trial NCT05448534: Electroencephalographic Patterns of Septic Patients and Its Correlation With Cognitive Outcomes
Official title: Electroencephalographic Patterns of Septic Patients and Its Correlation With Cognitive Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sepsis
Keywords: Eletroencephalography
Sepsis
Septic shock
Critical care
cognitive dysfunction
Montreal cognitive assessment
Lead sponsor: Hospital Sao Domingos
Sponsor class: OTHER
First posted: 2022-07-07
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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:

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

Primary outcomes:
measure: Electroencephalographic patterns
timeFrame: 3 months after hospital discharge
measure: Cognitive evaluation
timeFrame: 3 months after hospital discharge
Secondary outcomes:
measure: electroencephalographic patterns and 28 days mortality .
timeFrame: 28 days
measure: Quality of Life (SF-36) after 3 months of discharge
timeFrame: 3 months after hospital discharge
Other outcomes:
Locations:
city: Sao Luis
country: Brazil
facility: Icu Hospital Sao Domingos
state: Maranhão
Study officials:
affiliation: Hospital Sao Domingos
name: JOSE AZEVEDO, MD, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.