Status EpilepticusNCT05647525
The Etiology of New-onset Status Epilepticus
An observational study of Status Epilepticus, run by Jie Liu at 1 site in China.
Trial summary
This study will help to identify the causes of new epilepsy and provide a basis for the development of a rational and standardized diagnosis and treatment plan to reduce the rate of disability and death. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Status Epilepticus
- What is being tested?
- Perform autoimmune encephalitis titer tests
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 30 Sep 2022
- How long will I take part?
- 6 Months
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients were selected strictly according to the inclusion and exclusion criteria from January 2021 to December 2022 at Sichuan Academy of Medical Sciences. Inpatient NOSE patients at Sichuan Provincial People's Hospital
Who may be able to join
- Clinical diagnosis of Status Epilepticus
- Sign the informed consent form
Who cannot join
- Patients with previous epilepsy
- Missing information such as basic information and treatment history
- Long-term smoking, alcohol and drug abuse
- Pregnant and breastfeeding women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sichuan Academy of Medical Sciences - Sichuan Provincial People's Hospital
This study will help to identify the causes of new epilepsy and provide a basis for the development of a rational and standardized diagnosis and treatment plan to reduce the rate of disability and death.
- Conditions
- Status Epilepticus
- Being tested
- Perform autoimmune encephalitis titer tests
- Medical subject headings
- Status Epilepticus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perform autoimmune encephalitis titer testsDiagnostic test
Also called We only follow up without intervention.
We only follow up without intervention.
| Study group | Role | What they receive |
|---|---|---|
| status epilepticus with autoimmune encephalitis; status epilepticus without autoimmune encephalitis | To study the relationship between autoimmune-related antibody titres and prognosis during the six-month follow-up Receives: Diagnostic Test: Perform autoimmune encephalitis titer tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death
Measured: 2021-12--2022-12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2022
- Study start1 Jan 2021
- Primary completion30 Aug 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Status EpilepticusStudies 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
- Prospective
- Enrolment
- 60 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Jie Liu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jie Liu, Sichuan Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05647525
- Sponsor's protocol ID
- Liujiessy
- Status last verified
- Dec 2022
- First submitted
- 4 Dec 2022
- Last updated
- 15 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sichuan Academy of Medical Sciences - Sichuan Provincial People's Hospital
- ClinicalTrials.gov ID
- NCT05647525
- Acronym / sponsor ID
- Liujiessy
- Conditions
- Status Epilepticus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Jie LiuUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Aug 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 12 Dec 2022 (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.
This study will help to identify the causes of new epilepsy and provide a basis for the development of a rational and standardized diagnosis and treatment plan to reduce the rate of disability and death.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| status epilepticus with autoimmune encephalitis; status epilepticus without autoimmune encephalitis | – | Diagnostic Test: Perform autoimmune encephalitis titer testsTo study the relationship between autoimmune-related antibody titres and prognosis during the six-month follow-up |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients were selected strictly according to the inclusion and exclusion criteria from January 2021 to December 2022 at Sichuan Academy of Medical Sciences. Inpatient NOSE patients at Sichuan Provincial People's Hospital
Key inclusion criteria (2 listed)
- Clinical diagnosis of Status Epilepticus
- Sign the informed consent form
Key exclusion criteria (4 listed)
- Patients with previous epilepsy
- Missing information such as basic information and treatment history
- Long-term smoking, alcohol and drug abuse
- Pregnant and breastfeeding women
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 |
|---|---|---|
| Perform autoimmune encephalitis titer testsAlso: We only follow up without intervention.We only follow up without intervention. | Diagnostic test | status epilepticus with autoimmune encephalitis; status epilepticus without autoimmune encephalitis |
Primary outcome
Death
Time frame: 2021-12--2022-12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Status Epilepticus
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Status Epilepticus, run by Jie Liu at 1 site in China.
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 2 inclusion and 4 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: finished, as of the sponsor's last update on 15 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Death (time frame: 2021-12--2022-12). 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 15 Dec 2022; AzTrials last refreshed its copy on 7 Nov 2026.