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

Autoimmune Encephalitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06456736
• Other study ID #: Xiangya_critical AE
• Status: Not yet recruiting
• Start date: June 2024
• Est. completion date: August 2024

Study information

• Verified date: June 2024
• Source: Central South University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: August 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Autoimmune Diseases of the Nervous System
• Autoimmune Encephalitis
• Encephalitis

Intervention

Other:
• None, non-interventional study
Not applicable, non-interventional study

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Central South University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Mortality	Rate of death at 12 months	12 months
Secondary	Rate of complications	Septic shock, hyponatremia	12 months