Clinical Features and Prognostic Markers in Adult Patients With AE Requiring ICU Treatment

NCT06456736 | Not Yet Recruiting

• 1 other identifier: Xiangya_critical AE
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

Autoimmune encephalitis (AE) is a potentially life-threatening inflammation of the central nervous system (CNS) and constitutes 20%-30% of encephalitis cases in adults AE often leads to subacute, severe, and debilitating encephalitis necessitating long-term management in a neurologic intensive care unit (ICU). This study aims to explore the predictive factors for poor clinical outcomes by analyzing the clinical characteristics and prognosis of adult patients with critical AE requiring ICU admission. Prospective observational single center study in neurologic ICU, the second Xiangya hospital, Central South University. All patients admitted to the ICU for probable or confirmed AE (2022 Chinese guidelines for diagnosis and treatment of AE) will be included. Factors associated with a poor prognosis will be identified by multivariate analysis using a logistic regression.

Conditions

Autoimmune Encephalitis

Outcome Measures

Primary Outcomes (1)

• Modified Rankin Scale

  The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It has become the most widely used clinic. mRS is scored on a scale of 0 to 6. The higher the score, the worse the prognosis

  12 months

Secondary Outcomes (2)

• Mortality

  12 months

• Rate of complications

  12 months

Interventions

None, non-interventional study OTHER

Not applicable, non-interventional study

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

200 patients admitted to the ICU for AE.

You may qualify if:

• Diagnosed as either ''definite'' or ''probable'' AE based on Chinese guidelines for diagnosis and treatment of AE (version 2022)
• Age ≥ 15 years
• Admission to an adult ICU during the course of the disease

You may not qualify if:

• Missing data on primary outcome
• ICU length of stay of 24 hours or less.

Sponsors & Collaborators

• Central South University: lead

MeSH Terms

Conditions

Autoimmune Diseases of the Nervous System

Condition Hierarchy (Ancestors)

Nervous System Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 6, 2024
• First Posted: June 13, 2024
• Study Start: June 1, 2024
• Primary Completion: July 1, 2024
• Study Completion: August 1, 2024
• Last Updated: June 13, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share