Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06403150
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-05-07
First Post:
2024-02-21
Brief Title:
The Efficacy and Safety of Levetiracetam Versus Fosphenytoin in Convulsive Status Epilepticus
Sponsor:
Dhaka Medical College
Organization:
Dhaka Medical College
Study Overview
Official Title:
The Efficacy and Safety of Levetiracetam Versus Fosphenytoin in Convulsive Status Epilepticus An Open Label Clinical Trial in Dhaka Medical College Hospital
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Status epilepticus SE is an emergency life-threatening medical condition that may cause irreversible cerebral damage Therefore the rapid and secure cessation of seizures and resuscitation is crucial Potent gamma-aminobutyric acid agonists including benzodiazepines are recommended as first-line treatments For the complete cessation of SE and prevention of recurrence long-acting antiepileptic drugs eg- FPHT are also required as second-line treatments along with short-acting benzodiazepines Intravenous fosphenytoin FPHT is associated with fewer adverse events such as life-threatening arrhythmia cardiac arrest hypotension and allergic reactions Levetiracetam LEV is considered to be effective for SE with less serious adverse events including dizziness somnolence headache and transient agitation but there have been no reports of arrhythmias hypotension Stevens-Johnson syndrome or hepatotoxicity Preceding studies show that levetiracetam is similarly effective and associated with fewer adverse effects than those of fosphenytoin Few trials have compared the effectiveness and safety of levetiracetam LEV and fosphenytoin FHP for status epilepticus worldwide Moreover genetic variation is likely to play a crucial role in the development of adverse drug reactions ADRs including drug resistance By far no study has yet been conducted addressing the issue of efficacy and safety between levetiracetam LEV and fosphenytoin FHP in status epilepticus in the context of the Bangladeshi population A comparative study of the efficacy and safety of levetiracetam LEV and fosphenytoin FHP will be expected to give more confidence for the use of the drug Considering this the study aims to assess the safety and efficacy of levetiracetam LEV and fosphenytoin FHP in status epilepticus This study finding has an implication in the treatment protocol which will be beneficial for the patients and physicians as well Furthermore it will give input to the policymaker for developing new guidelines regarding status epilepticus management and also encourage future research
Detailed Description:
A randomized control trial will be conducted in the Department of Neurology DMCH Ethical approval will be obtained from the DMCH ethical review board before the study After the selection of the subjects the nature purpose and benefit of the study will be explained to each subject their legal attendants in detail They will be encouraged for voluntary participation Informed written consent will be taken from the participants or their legal attendants Diagnosis of Status epilepticus will be made according to the criteria of the ILAE task force on classification of status epilepticus 2015 The history of previous disease and habits as well as demographics the type of SE seizure duration before treatment the cause of SE and family history will be recorded In both groups height and body weight were estimated from body habitus family information or patient records Blood pressure will be measured BMI will be calculated as weight kgheight m2 In all patients neurological assessment will be conducted routinely Randomized sampling methods will be applied for selecting study subjects Randomization will be carried out into two groups After that group A will be treated with FHP and group B will be treated with LEV Resuscitation and stabilization will be simultaneously performed to ensure airway patency oxygen inhalation to prevent cerebral hypoxia securing intravenous access maintenance of blood pressure Routine laboratory investigations full blood count blood glucose electrolytes calcium magnesium liver function test renal function test will be done EEG will be done in all patients
At first Diazepam will be intravenously administered at 10 mg to all patients Then if SE Status Epilepticus is not controlled within 20 minutes from Diazepam needle time study participants will be rapidly randomized and allocated to the FPHT and LEV groups
In the FPHT group FPHT at 20 mgkg Phenytoin equivalent dose of 15 mgkg will be intravenously administered in 100mL of normal saline at an administration rate not exceeding 3mgkgmin or 150 mgmin
In the LEV group LEV at 60 mgkg max dose 4500 mg will be intravenously administered in 100mL of normal saline at an administration rate of 2-5mgkgmin or over 10 minutes
Then after 30 minutes following FPHTLEV needle time reassessment of the patient will be done to determine the outcomes
If seizures continue after 30 minutes following FPHTLEV needle time then other injectable agents eg- if FPHT given previously can give LEV intravenously at 60 mgkg max dose 4500 mg or if LEV given previously can give FPHT intravenously at 20 mgkg Phenytoin equivalent dose of 15 mgkg will be given to the patient
If seizures still continue after 30 minutes patient will be transferred to intensive care and the standard of care will be given according to intensive care unit protocol
Once status controlled commence maintenance therapy with Levetiracetam 1000-1500 mg IV twice daily in case of Group-A patient or with FPHT 400 mgday IV in case of Group-B patient Subsequent anti-seizure medications will be given based on seizure semiology etiology electroencephalography EEG correlates and age of the patient
After the cessation of seizures electroencephalography EEG neuroimaging CT MRI brain CSF study other necessary investigations will be performed as needed FPHT or LEV will be randomized only for the first administration after diazepam and their subsequent administration will be not regulated The primary outcome will be the seizure cessation rate within 30 minutes of starting administration of the study drug Secondary outcomes will be the seizure recurrence rate within 24 hours which will be confirmed by an apparent seizure or non-convulsive seizure detected by EEG the serious adverse event rate throughout the observational period potentially induced by the study drugs such as cardiac arrest life-threatening arrhythmia respiratory arrest and hypotension and the intubation rate within 24hours All the information will be recorded in a structured data collection sheet
Patients will be followed up at 30 minutes 24 hours and at discharge after receiving medication and the following outcomes will be assessed seizure cessation rate seizure recurrence rate intubation rate all-cause in-hospital mortality adverse effects of drugs and mRS at discharge All data will be collected tabulated and analyzed statistically using a personal computer and the Statistical Package for Social Science SPSS version 26 IBM Chicago Illinois USA
At first Diazepam will be intravenously administered at 10 mg to all patients Then if SE Status Epilepticus is not controlled within 20 minutes from Diazepam needle time study participants will be rapidly randomized and allocated to the FPHT and LEV groups
In the FPHT group FPHT at 20 mgkg Phenytoin equivalent dose of 15 mgkg will be intravenously administered in 100mL of normal saline at an administration rate not exceeding 3mgkgmin or 150 mgmin
In the LEV group LEV at 60 mgkg max dose 4500 mg will be intravenously administered in 100mL of normal saline at an administration rate of 2-5mgkgmin or over 10 minutes
Then after 30 minutes following FPHTLEV needle time reassessment of the patient will be done to determine the outcomes
If seizures continue after 30 minutes following FPHTLEV needle time then other injectable agents eg- if FPHT given previously can give LEV intravenously at 60 mgkg max dose 4500 mg or if LEV given previously can give FPHT intravenously at 20 mgkg Phenytoin equivalent dose of 15 mgkg will be given to the patient
If seizures still continue after 30 minutes patient will be transferred to intensive care and the standard of care will be given according to intensive care unit protocol
Once status controlled commence maintenance therapy with Levetiracetam 1000-1500 mg IV twice daily in case of Group-A patient or with FPHT 400 mgday IV in case of Group-B patient Subsequent anti-seizure medications will be given based on seizure semiology etiology electroencephalography EEG correlates and age of the patient
After the cessation of seizures electroencephalography EEG neuroimaging CT MRI brain CSF study other necessary investigations will be performed as needed FPHT or LEV will be randomized only for the first administration after diazepam and their subsequent administration will be not regulated The primary outcome will be the seizure cessation rate within 30 minutes of starting administration of the study drug Secondary outcomes will be the seizure recurrence rate within 24 hours which will be confirmed by an apparent seizure or non-convulsive seizure detected by EEG the serious adverse event rate throughout the observational period potentially induced by the study drugs such as cardiac arrest life-threatening arrhythmia respiratory arrest and hypotension and the intubation rate within 24hours All the information will be recorded in a structured data collection sheet
Patients will be followed up at 30 minutes 24 hours and at discharge after receiving medication and the following outcomes will be assessed seizure cessation rate seizure recurrence rate intubation rate all-cause in-hospital mortality adverse effects of drugs and mRS at discharge All data will be collected tabulated and analyzed statistically using a personal computer and the Statistical Package for Social Science SPSS version 26 IBM Chicago Illinois USA
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None