Status EpilepticusNCT07853391
Predictors of Outcomes of Convulsive Status Epilepticus
An observational study of Status Epilepticus and Convulsive Status Epilepticus, run by Assiut University.
Trial summary
Status epilepticus is a life-threatening neurological emergency characterized by prolonged seizures or multiple seizures occurring without the patient regaining consciousness between episodes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Status Epilepticus, Convulsive Status Epilepticus
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Nov 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Adult patients presenting with convulsive status epilepticus admitted to the emergency, neurology, or intensive care departments at Assiut University Hospitals. The population includes individuals aged 18 years and older presenting with continuous convulsive seizure activity lasting more than 5 minutes or two or more discrete seizures without full recovery of consciousness between episodes.
Who may be able to join
- Age 18 years or older.
- Presentation with convulsive status epilepticus, defined as continuous convulsive seizure activity lasting more than 5 minutes or two or more discrete seizures without full recovery of consciousness between episodes.
Who cannot join
- Functional or dissociative (psychogenic non-epileptic) status.
- Acute cardiac arrest with motor phenomena due to cerebral anoxia.
- Movement disorders mimicking seizures (e.g., acute extrapyramidal side effects, chorea, or dyskinesias).
- Age younger than 18 years.
About this study
Official title: Predictors of Outcomes of Convulsive Status Epilepticus: A Hospital-Based Study
Status epilepticus is a life-threatening neurological emergency characterized by prolonged seizures or multiple seizures occurring without the patient regaining consciousness between episodes. Convulsive status epilepticus is associated with high rates of morbidity and mortality if not promptly recognized and controlled. While prognostic factors have been studied in various populations, data regarding clinical predictors and hospital outcomes in Upper Egypt remain limited.
The purpose of this prospective, hospital-based observational study is to identify the clinical predictors of short-term outcomes among adult patients presenting with convulsive status epilepticus admitted to Assiut University Hospitals.
Read more
All eligible participants aged 18 years and older admitted with convulsive status epilepticus will receive standard-of-care medical management according to institutional clinical protocols. Researchers will systematically collect clinical data, including demographic factors, seizure semiology and duration, underlying etiologies, laboratory tests, neuroimaging findings, and electroencephalography (EEG) results.
Participants will be followed throughout their hospital stay to assess functional outcome at discharge using the Modified Rankin Scale (mRS), in-hospital mortality, response to antiseizure treatment, development of refractory or super-refractory status epilepticus, requirement for intensive care unit (ICU) admission or mechanical ventilation, and length of hospital stay.
- Conditions
- Status Epilepticus, Convulsive Status Epilepticus
- Keywords
- Convulsive status epilepticus, Predictors of outcome, Refractory status epilepticus, Super-refractory status epilepticus, In-hospital mortality, Modified Rankin Scale, Seizure control, Mechanical ventilation, Intensive care unit
- Medical subject headings
- Status Epilepticus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Convulsive Status Epilepticus Cohort | Adult patients (aged 18 years and older) admitted to Assiut University Hospitals presenting with convulsive status epilepticus, defined as continuous convulsive seizure activity lasting more than 5 minutes or two or more discrete seizures without full recovery of consciousness between episodes. All enrolled participants receive standard-of-care medical management according to institutional guidelines, including first- and second-line antiseizure medications, anesthetic agents, and intensive care or mechanical ventilation when clinically required. Demographic characteristics, clinical features, etiology, laboratory investigations, neuroimaging, electroencephalography (EEG), and treatment responses are prospectively collected throughout hospitalization until discharge to determine clinical predictors of outcome. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Rankin Scale Score
Functional outcome assessed using the Modified Rankin Scale (mRS). The mRS is an ordinal scale ranging from 0 (no symptoms) to 6 (death). Scores 0-2 indicate functional independence, while scores 3-6 indicate functional dependence or death. Higher scores reflect worse clinical outcome.
Measured: Up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionNov 2027 (estimated)
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.
- More trials run by Assiut UniversityThe 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
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hagar Khaled Abo Daif, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07853391
- Sponsor's protocol ID
- Outcomes in Status Epilepticus
- Status last verified
- Sep 2026
- First submitted
- 26 Sep 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Outcomes of Convulsive Status Epilepticus: A Hospital-Based Study
- ClinicalTrials.gov ID
- NCT07853391
- Acronym / sponsor ID
- Outcomes in Status Epilepticus
- Conditions
- Status Epilepticus, Convulsive Status Epilepticus
- Keywords
- Convulsive status epilepticus, Predictors of outcome, Refractory status epilepticus, Super-refractory status epilepticus, In-hospital mortality, Modified Rankin Scale, Seizure control, Mechanical ventilation
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 1 Oct 2026 (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.
Status epilepticus is a life-threatening neurological emergency characterized by prolonged seizures or multiple seizures occurring without the patient regaining consciousness between episodes. Convulsive status epilepticus is associated with high rates of morbidity and mortality if not promptly recognized and controlled. While prognostic factors have been studied in various populations, data regarding clinical predictors and hospital outcomes in Upper Egypt remain limited.
The purpose of this prospective, hospital-based observational study is to identify the clinical predictors of short-term outcomes among adult patients presenting with convulsive status epilepticus admitted to Assiut University Hospitals.
All eligible participants aged 18 years and older admitted with convulsive status epilepticus will receive standard-of-care medical management according to institutional clinical protocols. Researchers will systematically collect clinical data, including demographic factors, seizure semiology and duration, underlying etiologies, laboratory tests, neuroimaging findings, and electroencephalography (EEG) results.
Participants will be followed throughout their hospital stay to assess functional outcome at discharge using the Modified Rankin Scale (mRS), in-hospital mortality, response to antiseizure treatment, development of refractory or super-refractory status epilepticus, requirement for intensive care unit (ICU) admission or mechanical ventilation, and length of hospital stay.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Convulsive Status Epilepticus Cohort | – | –Adult patients (aged 18 years and older) admitted to Assiut University Hospitals presenting with convulsive status epilepticus, defined as continuous convulsive seizure activity lasting more than 5 minutes or two or more discrete seizures without full recovery of consciousness between episodes. All enrolled participants receive standard-of-care medical management according to institutional guidelines, including first- and second-line antiseizure medications, anesthetic agents, and intensive care or mechanical ventilation when clinically required. Demographic characteristics, clinical features, etiology, laboratory investigations, neuroimaging, electroencephalography (EEG), and treatment responses are prospectively collected throughout hospitalization until discharge to determine clinical predictors of outcome. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult patients presenting with convulsive status epilepticus admitted to the emergency, neurology, or intensive care departments at Assiut University Hospitals. The population includes individuals aged 18 years and older presenting with continuous convulsive seizure activity lasting more than 5 minutes or two or more discrete seizures without full recovery of consciousness between episodes.
Key inclusion criteria (2 listed)
- Age 18 years or older.
- Presentation with convulsive status epilepticus, defined as continuous convulsive seizure activity lasting more than 5 minutes or two or more discrete seizures without full recovery of consciousness between episodes.
Key exclusion criteria (4 listed)
- Functional or dissociative (psychogenic non-epileptic) status.
- Acute cardiac arrest with motor phenomena due to cerebral anoxia.
- Movement disorders mimicking seizures (e.g., acute extrapyramidal side effects, chorea, or dyskinesias).
- Age younger than 18 years.
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
Modified Rankin Scale Score
Time frame: Up to 30 days
Functional outcome assessed using the Modified Rankin Scale (mRS). The mRS is an ordinal scale ranging from 0 (no symptoms) to 6 (death). Scores 0-2 indicate functional independence, while scores 3-6 indicate functional dependence or death. Higher scores reflect worse clinical outcome.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
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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.
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 Status Epilepticus and Convulsive Status Epilepticus, run by Assiut 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 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: opening soon, as of the sponsor's last update on 1 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
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 Score (time frame: Up to 30 days). 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 Oct 2026.