Electroencephalographic Patterns of Septic Patients and Its Correlation With Cognitive Outcomes

Sepsis Clinical Trial

Official title:

Electroencephalographic Patterns of Septic Patients and Its Correlation With Cognitive Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05448534
• Other study ID #: 54
• Status: Completed
• Start date: November 1, 2021
• Est. completion date: February 24, 2023

Study information

• Verified date: February 2023
• Source: Hospital Sao Domingos
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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..

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: February 24, 2023
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Sepsis

Intervention

Diagnostic Test:
• Eletroencephalography
We used Sinek and Young Scale to classify electroencephalographic patterns and cognitive outcome with MOCA score.

Locations

Country	Name	City	State
Brazil	Icu Hospital Sao Domingos	Sao Luis	Maranhão

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Sao Domingos

Country where clinical trial is conducted

Brazil, 

References & Publications (6)

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 — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 months after hospital discharge
Primary	Cognitive evaluation	Cognitive dysfunction measured by Montreal Cognitive Assessment (MoCA)	3 months after hospital discharge
Secondary	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.	28 days
Secondary	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.	3 months after hospital discharge