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AI-based screening and identification of serum metabolites associated with the diagnosis of sepsis associated encephalopathy: a prospective, observational, multicenter study

Early predictive value of serum metabolites in sepsis associated encephalopathy

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500100875
Enrollment
Unknown
Registered
2025-04-16
Start date
2024-08-18
Completion date
Unknown
Last updated
2025-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sepsis

Interventions

SAE group :None
non-SAE group:None

Sponsors

Xijing Hospital, the First Affiliated Hospital of PLA Air Force Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. According to the sepsis-3.0 criteria jointly released by the Society of Critical Care Medicine (SCCM) in the United States and the European Society of Intensive Care Medicine (ESICM) in 2021, sepsis is clearly diagnosed. 2. The diagnosis of SAE (Sepsis-Associated Encephalopathy): SAE is defined as a Glasgow Coma Scale (GCS) score <15 in sepsis patients, or the presence of delirium (including inattention, disorientation, altered thinking, psychomotor retardation and/or agitation) in medical records. Delirium is assessed twice a day, in the morning and evening, and the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) is used as the standard for diagnosing SAE. Other causes affecting neurological function should be excluded, including drug effects, metabolic disorders, primary central nervous system diseases (such as meningitis, encephalitis, cerebrovascular disease, epilepsy, etc.) and non-infectious systemic inflammatory responses (such as burns, severe pancreatitis, trauma, etc.). Patients are divided into SAE group and non - SAE group according to the disease progression. 3. The patient is admitted to the ICU for the first time and the duration of ICU stay is more than 72 hours. 4. The subject has the ability to understand this study and is willing to participate in it, and has signed the informed consent form. For subjects without the capacity to act, if the investigator believes that the subject's participation in the trial is in his/her own interest, the informed consent form should be signed by his/her legal guardian and explained in the original medical records and other relevant documents.

Exclusion criteria

Exclusion criteria: 1.Patients with primary central nervous system diseases, intracranial infections, trauma, vascular dementia, Alzheimer's disease, and other diseases that affect consciousness and mental state; 2.Acute brain injury as the reason for ICU admission (such as meningitis, encephalitis, status epilepticus, traumatic brain injury, or stroke); 3.Other diseases affecting consciousness, such as hepatic encephalopathy; 4.According to the investigator's judgment, any physical examination findings, laboratory abnormalities, and/or any medical history of the subject may endanger their safety due to participation in the study.

Design outcomes

Primary

MeasureTime frame
Differential serum metabolites represented by 4-hydroxyphenylacetic acid;

Secondary

MeasureTime frame
The assay index represented by lactic acid;

Countries

China

Contacts

Public ContactZhang Xijing

Xijing Hospital, the First Affiliated Hospital of PLA Air Force Medical University

zhangxj918@163.com+86 133 8492 0881

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026