Status EpilepticusNCT03245099
Management of Non Convulsive Status Epilepticus
An observational study of Status Epilepticus, run by Assiut University at 1 site in Egypt.
Trial summary
Non convulsive status epilepticus is a persistent change in behavioural and or mental process from baseline associated with continuous epileptiform activity in electroencephalograph,it occur in about 50 percent in patients with coma and convulsions and in 8-13 percent in intensive care unit patients Read more about this study
- Who is it for?
- Ages 12 months to 18 years
- Conditions the study is for
- Status Epilepticus
- What is being tested?
- cross sectional
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- Dec 2017to Apr 2019
- 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 12 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: * Patients 1-18 years * Generalized tonic clonic convulsions and prolonged post ictal period more than 30 minutes * Un explained coma ,stupor,confusion and psychic or speech disorder
Who may be able to join
- patients who have generalized tonic colonic convulsions and prolonged post ictal state more than 30 minutes
- patients presented with un explained psychic or speech disorder
- patients presented with stupor or confusion
- Patients presented with un explained coma
Who cannot join
- patients with progressive neurological disease
- Patients with severe cerebral anoxia
- Patients with liver or hepatic impairment
Trial locations and contacts
1 site in 1 country.
About this study
Non convulsive status epilepticus is a persistent change in behavioural and or mental process from baseline associated with continuous epileptiform activity in electroencephalograph,it occur in about 50 percent in patients with coma and convulsions and in 8-13 percent in intensive care unit patients
Read the detailed description
Early recognition and treatment of non convulsive status epilepticus are essential to optimize response to treatment and to prevent neurological sequelae, over diagnosis and aggressive use of anticonvulsants can contribute to morbidity and mortality.It displays great diversity in response to anticonvulsants,therefore treatment in intensive care units is required for selected cases .The aetiology and clinical forms are strong predictors for the overall prognosis.Treatment is poorly understood and follows the standard regimen for convulsive status epilepticus
- Conditions
- Status Epilepticus
- Being tested
- cross sectional
- Medical subject headings
- Status Epilepticus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cross sectionalOther
Electroencephalograph will be done to all patients who fulfill the inclusion criteria to detect presence of electrical discharge with in the brain.Complete blood count ,liver function test ,kidney function test ,blood glucose level and serum electrolytes will be done to selected cases according to the clinical presentation
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of cured patients
Number of cured patients
Measured: An average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2017
- Study startDec 2017 (estimated)
- Primary completionDec 2018 (estimated)
- Study completionApr 2019 (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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rewaa Mohammed, Assiut University
- Investigators
- Rewaa Mohammed, MD, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03245099
- Sponsor's protocol ID
- MONCSE
- Status last verified
- Aug 2017
- First submitted
- 4 Aug 2017
- Last updated
- 10 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Non Convulsive Status Epilepticus
- ClinicalTrials.gov ID
- NCT03245099
- Acronym / sponsor ID
- MONCSE
- Conditions
- Status Epilepticus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Dec 2017 (estimated)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Apr 2019 (estimated)
- First posted
- 10 Aug 2017 (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.
Non convulsive status epilepticus is a persistent change in behavioural and or mental process from baseline associated with continuous epileptiform activity in electroencephalograph,it occur in about 50 percent in patients with coma and convulsions and in 8-13 percent in intensive care unit patients
Detailed description
Early recognition and treatment of non convulsive status epilepticus are essential to optimize response to treatment and to prevent neurological sequelae, over diagnosis and aggressive use of anticonvulsants can contribute to morbidity and mortality.It displays great diversity in response to anticonvulsants,therefore treatment in intensive care units is required for selected cases .The aetiology and clinical forms are strong predictors for the overall prognosis.Treatment is poorly understood and follows the standard regimen for convulsive status epilepticus
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 12 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- * Patients 1-18 years * Generalized tonic clonic convulsions and prolonged post ictal period more than 30 minutes * Un explained coma ,stupor,confusion and psychic or speech disorder
Key inclusion criteria (4 listed)
- patients who have generalized tonic colonic convulsions and prolonged post ictal state more than 30 minutes
- patients presented with un explained psychic or speech disorder
- patients presented with stupor or confusion
- Patients presented with un explained coma
Key exclusion criteria (3 listed)
- patients with progressive neurological disease
- Patients with severe cerebral anoxia
- Patients with liver or hepatic impairment
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 |
|---|---|---|
| cross sectionalElectroencephalograph will be done to all patients who fulfill the inclusion criteria to detect presence of electrical discharge with in the brain.Complete blood count ,liver function test ,kidney function test ,blood glucose level and serum electrolytes will be done to selected cases according to the clinical presentation | Other | – |
Primary outcome
Number of cured patients
Time frame: An average of 1 year
Number of cured patients
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2017.
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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.
Rewaa Mohammed, MD principal investigator
Assiut University
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 Assiut University at 1 site in Egypt.
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 4 inclusion and 3 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 10 Aug 2017. 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 Egypt. 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 Gamal Askar, MD (01111686162, Gamal.askar@med.au.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of cured patients (time frame: An average of 1 year). 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 10 Aug 2017.