Electroencephalographic Patterns of Septic Patients and Its Correlation With Cognitive Outcomes

NCT05448534 | Completed

• 1 other identifier: 54
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

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..

Conditions

Sepsis

Keywords

Eletroencephalography; Sepsis; Septic shock; Critical care; cognitive dysfunction; Montreal cognitive assessment

Outcome Measures

Primary Outcomes (2)

• 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

• Cognitive evaluation

  Cognitive dysfunction measured by Montreal Cognitive Assessment (MoCA)

  3 months after hospital discharge

Secondary Outcomes (2)

• electroencephalographic patterns and 28 days mortality .

  28 days

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

  3 months after hospital discharge

Interventions

Eletroencephalography DIAGNOSTIC_TEST

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Hospital Sao Domingos: lead

Study Sites (1)

Icu Hospital Sao Domingos

São Luís, Maranhão, 65060-645, Brazil

Location

Related 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 Predict Mortality in Septic Intensive Care Unit Patients. PLoS One. 2015 Oct 8;10(10):e0139969. doi: 10.1371/journal.pone.0139969. eCollection 2015.

  PMID: 26447697 RESULT

• 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.

  PMID: 8627969 RESULT

• 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.

  PMID: 20978258 RESULT

• 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.

  PMID: 19384197 RESULT

• 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.

  PMID: 1552002 RESULT

• 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.

  PMID: 25482125 RESULT

MeSH Terms

Conditions

Sepsis; Shock, Septic; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• JOSE AZEVEDO, MD, PhD

  Hospital Sao Domingos

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ICU Coordinator

Study Record Dates

• First Submitted: June 29, 2022
• First Posted: July 7, 2022
• Study Start: November 1, 2021
• Primary Completion: November 30, 2022
• Study Completion: February 24, 2023
• Last Updated: February 28, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)