- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07853391
Predictors of Outcomes of Convulsive Status Epilepticus
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.
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 Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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.
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Observational Models: COHORT
- Time Perspectives: PROSPECTIVE
Cohorts and Interventions
Group / Cohort |
|---|
|
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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. |
Up to 30 days
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Outcomes in Status Epilepticus
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