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Exploration of the Prognostic Value of Immunoinflammatory Indicators and Vital Signs Trajectories in Patients with Acute Brain Injury: A Study Utilizing MIMIC-IV, eICU, and Single-Center Validation

Exploration of the Prognostic Value of Immunoinflammatory Indicators and Vital Signs Trajectories in Patients with Acute Brain Injury: A Study Utilizing MIMIC-IV, eICU, and Single-Center Validation

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600119031
Enrollment
Unknown
Registered
2026-02-14
Start date
2026-02-21
Completion date
Unknown
Last updated
2026-02-16

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

Conditions

Severe Brain Injury (including traumatic brain injury, subarachnoid hemorrhage, intracranial hemorrhage, acute ischemic stroke, etc.)

Interventions

Observation group:None

Sponsors

Huashan Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.18 years old and above. 2.Clearly Diagnosed with Acute Brain Injury (ABI);ABI definition: sudden, non degenerative, reversible or irreversible brain tissue structure or function damage, which usually starts within minutes to hours, and may lead to consciousness disturbance, neurological deficit, intracranial pressure rise or brain death, including but not limited to: (1) traumatic brain injury (TBI); (2) Spontaneous intracerebral hemorrhage (ICH); (3) Aneurysmal subarachnoid hemorrhage (SAH);(4) Cerebral infarction, status epilepticus, hypoxic ischemic encephalopathy, encephalitis 3.A minimum of any two laboratory tests required for CALLY calculation were obtained within 0–24 hours after ICU admission(CRP, albumin, peripheral lymphocytes), and the index can be calculated by unit conversion; Other composite indicators (car, NLR, PNI, SII). 4.There is continuous or intermittent vital signs data recorded within 0-72 hours after ICU admission(map, HR, RR, body temperature, SpO2>= 2 categories), meet the minimum recording frequency and duration requirements for trajectory / feature extraction (for example, record at least once every 1 – 4 hours); 5.Information on primary outcomes (in-hospital mortality) and key time variables (admission/discharge time) is available for determination.

Exclusion criteria

Exclusion criteria: 1.Age <18 years, or no valid age information available; 2.Patient with brain tumor or metabolic encephalopathy; 3.The laboratory tests constituting the CALLY index were entirely missing or could not be effectively unit-converted within 0–24 hours after ICU admission; 4.Key outcome or time information cannot be determined.e.g., in-hospital death/missing discharge disposition, which cannot be completed/retrieved via the database or medical record archiving; 5.Special populations whose conditions significantly affect the interpretation of CALLY and are difficult to adequately address in sensitivity analysis; (1) Patients with active hematologic malignancies and significant chemotherapy-induced lymphocytopenia; (2) Patients with confirmed severe liver failure (e.g., Child-Pugh class C or those requiring evaluation for liver transplantation) resulting in significantly decreased albumin levels that cannot be clearly differentiated from inflammatory or nutritional causes; (3)Patients receiving high-dose corticosteroid/immunosuppressive therapy (e.g., in the early post-solid organ transplantation period) with profoundly abnormal immune cell counts that show a weak correlation with ABI.

Design outcomes

Primary

MeasureTime frame
All cause death in hospital;

Secondary

MeasureTime frame
ICU length of stay, total length of stay;All cause death in 28 days;Functional Prognosis;

Countries

China

Contacts

Public ContactShuixiang Deng

Huashan Hospital, Fudan University

shuixiang2@126.com+86 21 52887353

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 19, 2026