SepsisNCT05448534
Electroencephalographic Patterns of Septic Patients and Its Correlation With Cognitive Outcomes
An observational study of Sepsis, run by Hospital Sao Domingos at 1 site in Brazil.
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.. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis
- What is being tested?
- Eletroencephalography
- How many people
- 160 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Nov 2021to 24 Feb 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
- -
Who cannot join
- CNS infections,
- Structural abnormalities of the CNS, known
- Liver or uremic encephalopathy,
- Advanced dementia (Mini mental < 9),
- Psychiatric disorder
- Epilepsy.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Sepsis
- Being tested
- Eletroencephalography
- Keywords
- Eletroencephalography, Sepsis, Septic shock, Critical care, cognitive dysfunction, Montreal cognitive assessment
- Medical subject headings
- Sepsis, Shock, Septic, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EletroencephalographyDiagnostic test
Also called Montreal Cognitive Assessment (MoCA), Sinek and young scales
We used Sinek and Young Scale to classify electroencephalographic patterns and cognitive outcome with MOCA score.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months after hospital discharge
Cognitive evaluation
Cognitive dysfunction measured by Montreal Cognitive Assessment (MoCA)
Measured: 3 months after hospital discharge
Secondary outcomes (2)
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.
Measured: 28 days
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.
Measured: 3 months after hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2022
- Study start1 Nov 2021
- Primary completion30 Nov 2022
- Study completion24 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Sao Domingos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, José Raimundo Araujo de Azevedo, Hospital Sao Domingos
- Investigators
- JOSE AZEVEDO, MD, PhD, Study director, Hospital Sao Domingos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05448534
- Sponsor's protocol ID
- 54
- Status last verified
- Feb 2023
- First submitted
- 29 Jun 2022
- Last updated
- 28 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 26447697Eidelman 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 8627969Iwashyna 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 20978258Oddo 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 19384197Young 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 1552002Hosokawa 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
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electroencephalographic Patterns of Septic Patients and Its Correlation With Cognitive Outcomes
- ClinicalTrials.gov ID
- NCT05448534
- Acronym / sponsor ID
- 54
- Conditions
- Sepsis
- Keywords
- Eletroencephalography, Sepsis, Septic shock, Critical care, cognitive dysfunction, Montreal cognitive assessment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Hospital Sao DomingosUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 24 Feb 2023 (actual)
- First posted
- 7 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
- -
Key exclusion criteria (6 listed)
- CNS infections,
- Structural abnormalities of the CNS, known
- Liver or uremic encephalopathy,
- Advanced dementia (Mini mental < 9),
- Psychiatric disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EletroencephalographyAlso: Montreal Cognitive Assessment (MoCA), Sinek and young scalesWe used Sinek and Young Scale to classify electroencephalographic patterns and cognitive outcome with MOCA score. | Diagnostic test | – |
Primary outcome
Electroencephalographic patterns
Time frame: 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
Time frame: 3 months after hospital discharge
Cognitive dysfunction measured by Montreal Cognitive Assessment (MoCA)
2 secondary outcomes
electroencephalographic patterns and 28 days mortality .
Time frame: 28 days
Quality of Life (SF-36) after 3 months of discharge
Time frame: 3 months after hospital discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2023.
- Results publication: PubMed 26447697Azabou 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.
- Results publication: PubMed 8627969Eidelman LA, Putterman D, Putterman C, Sprung CL. The spectrum of septic encephalopathy. Definitions, etiologies, and mortalities. JAMA. 1996 Feb 14;275(6):470-3.
- Results publication: PubMed 20978258Iwashyna 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.
- Results publication: PubMed 19384197Oddo 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.
- Results publication: PubMed 1552002Young 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.
- Results publication: PubMed 25482125Hosokawa 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
JOSE AZEVEDO, MD, PhD study director
Hospital Sao Domingos
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis, run by Hospital Sao Domingos at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Electroencephalographic patterns (time frame: 3 months after hospital discharge). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05448534, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2023; AzTrials last refreshed its copy on 6 Nov 2026.