Clinical Features and Prognostic Markers in Adult Patient... | NCT06456736

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

NCT06456736

Sponsor

Central South University

Status

Unknown status

Last Update Posted

Jun 13, 2024Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Autoimmune Encephalitis

Interventions

None, non-interventional study

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2024Estimated

Primary Completion Date

Jul 2024Estimated

Completion Date

Aug 2024Estimated

First Submitted Date

Jun 6, 2024

First Submission Date that Met QC Criteria

Jun 12, 2024

First Posted Date

Jun 13, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 12, 2024

Last Update Posted Date

Jun 13, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
None, non-interventional study	Other	Not applicable, non-interventional study

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Mortality	Rate of death at 12 months	12 months
Rate of complications	Septic shock, hyponatremia	12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

200 patients admitted to the ICU for AE.

Sampling Method

Non-Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D020274	Autoimmune Diseases of the Nervous System

Ancestor Terms

ID	Term
D009422	Nervous System Diseases
D001327	Autoimmune Diseases
D007154	Immune System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided