An observational study in Sepsis, Sepsis Associated Encephalopathy and Sepsis and Septic Shock, sponsored by Xiangya Hospital of Central South University. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-08-12.
Sponsored by Xiangya Hospital of Central South University · Observational
To characterize the electroencephalogram (EEG) features of sepsis patients with distinct inflammatory response phenotypes, dynamically track their evolutionary trajectories, and analyze their associations with long-term changes in cognitive function.
1,078 studies on the registry are indexed under Shock, Septic; 232 are open to participants now.
This study's planned enrollment of 78 is below the median of 108 across 406 observational studies indexed under Shock, Septic.
Browse Shock, Septic studies →Xiangya Hospital of Central South University is the lead sponsor of 174 studies on the registry; 77 are open to participants now.
Compared within Shock, Septic, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Sepsis. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Adult sepsis patients admitted to ICU at Xiangya Hospital, diagnosed according to Sepsis-3.0 criteria, with expected survival ≥24 hours. Patients with primary CNS diseases, post-CPCR status, pregnancy/lactation, or contraindications to EEG monitoring will be excluded.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Acute cerebrovascular disease (e.g., hemiplegia, cranial nerve palsy) Central nervous system infection (e.g., pleocytosis in cerebrospinal fluid) Organic or metabolic encephalopathy (e.g., hepatic, renal, pulmonary, pancreatic, or severe inherited metabolic disorders) Drug-related encephalopathy (e.g., antipsychotic-associated encephalopathy, serotonin syndrome, neurotoxic antibiotics) Other structural or immunological brain diseases (e.g., traumatic brain injury, intracranial neoplasm, encephalopathy)
- Inability to cooperate with or tolerate scalp EEG electrode placement (e.g., extensive scalp trauma or open scalp infection)
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Septic patients displaying serum Interleukin-6 (IL-6) ≥ 400 pg/mL upon ICU admission (Day 1) .
Device: EEG monitoring
Septic patients displaying serum Interleukin-6 (IL-6) \< 400 pg/mL upon ICU admission (Day 1) .
Device: EEG monitoring
Standard sepsis bundle treatment + 72-hour quantitative continuous EEG monitoring + structured long-term cognitive follow-up.
Quantified EEG Features and Young Classification Grade
Description: Power spectral density (delta, theta, alpha, beta frequency bands), relative delta band power ratio (1-4 Hz), epileptiform discharge frequency, burst-suppression ratio, and Young EEG grading (Grade I to VI, double-blinded expert consensus reading).
Time frame: 72 hours after enrollment
Favorable Neurological Prognosis Rate (CPC Score)
Neurological outcome assessed using the Cerebral Performance Category (CPC) scale. The CPC score ranges from 1 to 5, with lower scores indicating better neurological function. CPC scores of 1-2 indicate favorable neurological outcomes, whereas CPC scores of 3-5 indicate unfavorable neurological outcomes.
Time frame: Baseline (Day 1), Day 2, Day 3, Day 7, Day 30, Day 90, and Day 180 post-enrollment.
Montreal Cognitive Assessment (MoCA) Score
Cognitive function assessed using the Montreal Cognitive Assessment (MoCA) scale. The total MoCA score ranges from 0 to 30, with higher scores indicating better cognitive function. A MoCA score \<26 is defined as cognitive impairment.
Time frame: Baseline (Day 1), Day 2, Day 3, Day 7, Day 30, Day 90, and Day 180 post-enrollment.
Mortality
All-cause mortality collected through electronic medical records and structured telephone follow-up.
Time frame: Day 30, Day 90, and Day 180 post-enrollment.
Length of ICU Stay
Total duration of stay in the Intensive Care Unit in days.
Time frame: Up to 180 days post-enrollment.
Health-Related Quality of Life (EQ-5D-5L Index)
Health-related quality of life assessed using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) Index. The EQ-5D-5L index score ranges from -0.594 to 1.000, with higher scores indicating better health-related quality of life.
Time frame: Day 30, Day 90, and Day 180 post-enrollment.
Plan to share: No
Start is estimated for Aug 2026; primary completion for Dec 2026, 4 months later.
Of 189 non-industry observational studies under Shock, Septic, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 47. This study's planned 4 months is below that.
Counting every sponsor, half of 202 studies reached it within 25 months; a quarter within 12 and three quarters within 47.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Xiangya Hospital of Central South University →