Status EpilepticsNCT02269137
Assessment of Severity and Prognosis for Patients With Status Epileptics(SE)
An observational study of Status Epileptics, run by Xijing Hospital at 1 site in China.
Trial summary
To characterize the functional outcomes and prognostic factors for convulsive status epilepticus (SE) and to further develop and validate a simple and practicable scoring system for outcome prediction. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Status Epileptics
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Mar 2008to Dec 2017
- How long will I take part?
- 3 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with status epilepticus
Who may be able to join
- 30 min or more of (1) continuous clinical seizure activities or (2) recurrent seizure activities without recovery(returning to baseline)between seizures;
- clinical data is complete.
Who cannot join
- hypoglycemia SE;psychogenic SE;any other pseudo-SE
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Department of Neurology, Xijing Hospital
Xi'an, Shaanxi, 710032
Wen Jiang, MD, 02984771319, jiangwen@fmmu.edu.cn
About this study
Official title: Assessment of Severity and Prognosis for Patients With Status Epileptics
To characterize the functional outcomes and prognostic factors for convulsive status epilepticus (SE) and to further develop and validate a simple and practicable scoring system for outcome prediction.
Read the detailed description
- Retrospectively study all patients with convulsive SE treated between March, 2008, and November, 2014.
- Develop a scoring system for outcome prediction.
- Prospectively validate the predictive accuracy of the scoring system
- Conditions
- Status Epileptics
- Keywords
- status epileptics, prognosis, risk factor, outcome
What is being measured
The primary outcome is the main question the study is designed to answer.
The modified Rankin scale
Measured: 3 months after discharge
Secondary outcomes (1)
The modified Rankin scale
Measured: on discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2014 (estimated)
- Study startMar 2008
- Primary completionAug 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Status EpilepticsStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- 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
- Enrolment
- 200 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wen Jiang, MD, Study director, The Department of Neurology, Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02269137
- Sponsor's protocol ID
- Xijing-49
- Status last verified
- Dec 2015
- First submitted
- 15 Oct 2014
- Last updated
- 1 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Severity and Prognosis for Patients With Status Epileptics
- ClinicalTrials.gov ID
- NCT02269137
- Acronym / sponsor ID
- Xijing-49
- Conditions
- Status Epileptics
- Keywords
- status epileptics, prognosis, risk factor, outcome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Aug 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 20 Oct 2014 (estimated)
- 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.
To characterize the functional outcomes and prognostic factors for convulsive status epilepticus (SE) and to further develop and validate a simple and practicable scoring system for outcome prediction.
Detailed description
- Retrospectively study all patients with convulsive SE treated between March, 2008, and November, 2014.
- Develop a scoring system for outcome prediction.
- Prospectively validate the predictive accuracy of the scoring system
Study design
- Observational model
- Cohort
- Target follow-up
- 3 Months
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with status epilepticus
Key inclusion criteria (2 listed)
- 30 min or more of (1) continuous clinical seizure activities or (2) recurrent seizure activities without recovery(returning to baseline)between seizures;
- clinical data is complete.
Key exclusion criteria (1 listed)
- hypoglycemia SE;psychogenic SE;any other pseudo-SE
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The modified Rankin scale
Time frame: 3 months after discharge
1 secondary outcome
The modified Rankin scale
Time frame: on discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jan 2016.
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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.
Wen Jiang, MD study director
The Department of Neurology, Xijing Hospital
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 Epileptics, run by Xijing Hospital 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 1 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 1 Jan 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wen Jiang, MD (02984771319, jiangwen@fmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The modified Rankin scale (time frame: 3 months after discharge). 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 1 Jan 2016.