The primary objective is to determine the most effective and/or the least effective treatment of benzodiazepine-refractory status epilepticus (SE) among patients older than 2 years. There are three active treatment arms being compared: fosphenytoin (FOS),levetiracetam (LEV), and valproic acid (VPA). The second objective is comparison of three drugs with respect to secondary outcomes. The final objective is to ensure that the trial is informative for treatment of established SE in children by describing the effectiveness, safety, and rate of adverse reactions of these drugs in children.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
478
Number of Participants With Clinical Cessation of Status Epilepticus - Intention to Treat
Determined by the absence of clinically apparent seizures and improving consciousness at 1 hour without other anticonvulsant medications. Intention to treat
Time frame: Within 60 minutes after the start of study drug infusion
Number of Participants With Clinical Cessation of Status Epilepticus - Per-protocol Analysis
Determined by the absence of clinically apparent seizures and improving consciousness at 1 hour without other anticonvulsant medications. Per-protocol analysis
Time frame: Within 60 minutes after the start of study drug infusion
Number of Participants With Clinical Cessation of Status Epilepticus - Adjudicated Outcomes Analysis
Determined by the absence of clinically apparent seizures and improving consciousness at 1 hour without other anticonvulsant medications. The Adjudicated outcomes analysis is different from Outcome measure 1 because a central clinical phenomenology core of four neurologists adjudicated from the medical records the time to seizure cessation, the time in status epilepticus before trial-drug initiation, and the cause of the seizure. For each enrollment, two neurologists from this core group conducted independent initial reviews and then determined a consensus or consulted a third adjudicator, as needed. Adjudicators were unaware of the treatment assignments and made determinations by medical record review.
Time frame: Within 60 minutes after the start of study drug infusion
Number of Participants With Admission to Intensive Care Unit
ICU admission is recorded as occurring only if the ICU is the initial inpatient unit for the patient.
Time frame: Admission to intensive care unit after start of study drug infusion, where the ICU is the initial inpatient unit for the patient
Length of ICU Stay
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Banner University Medical Center - South Campus
Tucson, Arizona, United States
Banner University Medical Center-Tucson Campus
Tucson, Arizona, United States
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States
UC Davis Children's Hospital
Sacramento, California, United States
San Francisco General Hospital
San Francisco, California, United States
UCSF Medical Center
San Francisco, California, United States
UCSF Benioff Children's Hospital
San Francisco, California, United States
Stanford University Medical Center
Stanford, California, United States
Christiana Hospital
Newark, Delaware, United States
A.I.DuPont Hospital for Children
Wilmington, Delaware, United States
...and 55 more locations
Length of stay is determined by the number of calendar days after the day of ED arrival until hospital discharge or subject end-of-study.
Time frame: number of calendar days after the day of ED arrival until hospital discharge or subject end-of-study
Minutes From Start of Trial Drug Infusion to Termination of Seizures for Patients With Treatment Success
The time to termination of seizures is the interval from the start of study drug infusion to cessation of clinically apparent seizure in those who meet the primary outcome.
Time frame: start of drug infusion to seizure cessation
Number of Participants With Seizure Cessation Within 20 Minutes for Patients With Treatment Success
Number of participants with seizure cessation within 20 minutes of study drug initiation for patients with treatment success. This outcome measure was only reported in the Supplementary materials to the Primary Paper.
Time frame: within 20 minutes
Length of Hospital Stay
Length of hospital stay in days
Time frame: length of hospital stay