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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06456736
Other study ID # Xiangya_critical AE
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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