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Not yet recruitingNCT06456736Updated Jun 13, 2024

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

An observational study in Autoimmune Encephalitis, sponsored by Central South University. Not yet recruiting. Open to participants aged 15 Years and older. Per ClinicalTrials.gov, last updated 2024-06-13.

Sponsored by Central South University · Observational

From the registry’s dates

  • Primary completion was expected by Jul 2024, 2 years 4 months ago, but the record still lists the study as not yet recruiting.

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Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
200
Ages
15 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Autoimmune Encephalitis
03

In context

Autoimmune Diseases of the Nervous System

123 studies on the registry are indexed under Autoimmune Diseases of the Nervous System; 59 are open to participants now.

This study's planned enrollment of 200 is above the median of 160 across 57 observational studies indexed under Autoimmune Diseases of the Nervous System.

Browse Autoimmune Diseases of the Nervous System studies →

Lead sponsor

Central South University is the lead sponsor of 135 studies on the registry; 32 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

200 patients admitted to the ICU for AE.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Missing data on primary outcome
  • ICU length of stay of 24 hours or less.
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
200 participants (estimated)
Patient registry
No

Interventions

  • OtherNone, non-interventional study

    Not applicable, non-interventional study

06

What researchers measure

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

    Time frame: 12 months

Secondary outcomes

  1. Mortality

    Rate of death at 12 months

    Time frame: 12 months

  2. Rate of complications

    Septic shock, hyponatremia

    Time frame: 12 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Jun 2024; primary completion for Jul 2024, 1 month later.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 6, 2024
First posted
Jun 13, 2024
StartEst.
Jun 2024
Primary completionEst.
Jul 2024
CompletionEst.
Aug 2024
Last update
Jun 13, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 13, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06456736
Responsible party
Lixia Qin (Principal Investigator, Central South University) — Principal investigator
First posted
Jun 13, 2024
Start date
Jun 2024 (estimated)
Primary completion
Jul 2024 (estimated)
Completion
Aug 2024 (estimated)
Last update
Jun 13, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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