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Clinical study on the predictive role of bile acid metabolism analysis based on fourth-generation cognitive AI technology in the early identification of sepsis.

Clinical study on the predictive role of bile acid metabolism analysis based on fourth-generation cognitive AI technology in the early identification of sepsis.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300077483
Enrollment
Unknown
Registered
2023-11-09
Start date
2023-12-01
Completion date
Unknown
Last updated
2023-11-13

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

Conditions

sepsis

Interventions

Gold Standard:qSOFA score
Index test:Cognitive AI and bile acid testing.

Sponsors

East Hospital Affiliated to Tongji University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Age range: 18-80 years, both genders. 2. The diagnostic criteria for sepsis in Sepsis 3.0 are as follows: For patients with infection or suspected infection, when the qSOFA score (respiratory rate = 22 breaths/min, altered mental status, and systolic blood pressure = 100 mmHg, with 1 point assigned to each criterion) is = 2, further assessment should be conducted to determine if the patient has organ dysfunction. If the patient's SOFA score changes by = 2 points, it indicates the presence of organ dysfunction and the diagnosis of sepsis. The diagnostic criteria for septic shock are as follows: The patient has already been diagnosed with sepsis and presents with persistent hypotension despite adequate fluid resuscitation, requiring vasopressor therapy to maintain a mean arterial pressure = 65 mmHg (1 mmHg = 0.133 kPa), and a serum lactate level > 2 mmol/L. 3. The informed consent form should be signed.

Exclusion criteria

Exclusion criteria: 1. Age less than 18 years. 2. Patients with mental illness. 3. Pregnant or lactating women. 4. Patients with anuria (lack of urine production). 5. Patients with incomplete clinical data in the electronic medical record system. 6. Patients diagnosed with HIV. 7. Patients who refuse to participate.

Design outcomes

Primary

MeasureTime frame
Bile acid metabolism;Sensitivity;Specificity;Accuracy ;

Secondary

MeasureTime frame
arterial blood gas analysis;Analysis of acute infections;Emergency Biochemical analysis;procalcitonin;SOFA score;APACHE-? score;SIRS score;GCS score;

Countries

China

Contacts

Public ContactLijun Liao

East Hospital Affiliated to Tongji University

liao@pan-intelligence.com+86 138 1742 8913

Outcome results

None listed

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