Autoimmune EncephalitisNCT06456736
Clinical Features and Prognostic Markers in Adult Patients With AE Requiring ICU Treatment
An observational study of Autoimmune Encephalitis, run by Central South University.
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). Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Autoimmune Encephalitis
- What is being tested?
- None, non-interventional study
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Jun 2024to Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 200 patients admitted to the ICU for AE.
Who may be able to join
- 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
Who cannot join
- Missing data on primary outcome
- ICU length of stay of 24 hours or less.
About this study
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
- Being tested
- None, non-interventional study
- Medical subject headings
- Autoimmune Diseases of the Nervous System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
None, non-interventional studyOther
Not applicable, non-interventional study
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Secondary outcomes (2)
Mortality
Rate of death at 12 months
Measured: 12 months
Rate of complications
Septic shock, hyponatremia
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2024
- Study startJun 2024 (estimated)
- Primary completionJul 2024 (estimated)
- Study completionAug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autoimmune EncephalitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lixia Qin, Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06456736
- Sponsor's protocol ID
- Xiangya_critical AE
- Status last verified
- Jun 2024
- First submitted
- 6 Jun 2024
- Last updated
- 13 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Features and Prognostic Markers in Adult Patients With AE Requiring ICU Treatment
- ClinicalTrials.gov ID
- NCT06456736
- Acronym / sponsor ID
- Xiangya_critical AE
- Conditions
- Autoimmune Encephalitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Central South UniversityUniversity, hospital or other
- Study start
- Jun 2024 (estimated)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 13 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 200 patients admitted to the ICU for AE.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Missing data on primary outcome
- ICU length of stay of 24 hours or less.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| None, non-interventional studyNot applicable, non-interventional study | Other | – |
Primary outcome
Modified Rankin Scale
Time frame: 12 months
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
2 secondary outcomes
Mortality
Time frame: 12 months
Rate of complications
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2024.
- Individual participant dataSharing planned: No
Related trials for Autoimmune Encephalitis
RecruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
RecruitingObservational study
Natural History Study of Progressive Multifocal Leukoencephalopathy (PML)
Progressive Multifocal Leukoencephalopathy
RecruitingPhase 2
A Study in Participants With Anti-NMDAR Encephalitis and Anti-NMDAR Autoantibody-Associated Psychiatric Disease
Anti-N-methyl-D-aspartate Receptor (NMDAR) Encephalitis (ANRE), Anti-N-methyl-D-aspartate Receptor (NMDAR) Antibody-associated Psychiatric Disease
Not yet recruitingPhase 1/2
A Safety and Efficacy Study Evaluating CTX112 in Subjects With Refractory Neurologic Autoimmune Disease
Progressive Multiple Sclerosis (PMS), Neuromyelitis Optica
Recruiting
OPM- MEG in Non-immune And iMmune-medIated Neurological Disease
Autoimmune Encephalitis (AE), Acute Disseminated Encephalomyelitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Autoimmune Encephalitis, run by Central South University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Rankin Scale (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2024.