Ketamine add-on Therapy for Established Status Epilepticus Treatment Trial (KESETT)
ConditionStatus Epilepticus
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age1+
SponsorUniversity of Virginia
About this trial
The goal of this clinical trial is to determine if treatment of patients with two doses of ketamine plus levetiracetam versus levetiracetam alone leads to more effective control of status epilepticus.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
The patient was witnessed to have a convulsive seizure for greater than 5-minute duration
The patient received an adequate dose of benzodiazepines. The doses may be divided.
The last dose of a benzodiazepine was administered 5-30 minutes before study drug administration.
Continued or recurring seizures in the Emergency Department.
Disqualifiers
Known pregnancy
Prisoner
Opt-out identification or otherwise known to be previously enrolled in KESETT
Treatment with a second line anticonvulsant (FOS, PHT, VPA, LEV, phenobarbital, or other agents defined in the MoP) for this episode of SE
Trial design
Design model
Parallel
Treatments tested in this trial
Levetiracetam (LEV) (60 mg/Kg) + 1 mg/kg Ketamine (KET)
DrugThe study drug will be produced at the central pharmacy, a GMP facility at the University of California, Davis. Diluted formulations are expected to remain stable for months when stored at room temperature. Expiration dates for study drugs will be determined and adjusted based on ongoing stability testing performed on study drugs prepared at the GMP facility for the study. All three formulations will be transparent solutions. None of the formulations are reported to consistently cause adverse effects at the infusion site. The method of drug administration, including volume and rate of infusion, is identical for all three drugs. These factors ensure that drug administration will be blinded.
Levetiracetam (LEV) (60 mg/Kg) + 3 mg/kg Ketamine (KET)
DrugThe study drug will be produced at the central pharmacy, a GMP facility at the University of California, Davis. Diluted formulations are expected to remain stable for months when stored at room temperature. Expiration dates for study drugs will be determined and adjusted based on ongoing stability testing performed on study drugs prepared at the GMP facility for the study. All three formulations will be transparent solutions. None of the formulations are reported to consistently cause adverse effects at the infusion site. The method of drug administration, including volume and rate of infusion, is identical for all three drugs. These factors ensure that drug administration will be blinded.
Levetiracetam (LEV) (60 mg/Kg)
DrugThe study drug will be produced at the central pharmacy, a GMP facility at the University of California, Davis. Diluted formulations are expected to remain stable for months when stored at room temperature. Expiration dates for study drugs will be determined and adjusted based on ongoing stability testing performed on study drugs prepared at the GMP facility for the study. All three formulations will be transparent solutions. None of the formulations are reported to consistently cause adverse effects at the infusion site. The method of drug administration, including volume and rate of infusion, is identical for all three drugs. These factors ensure that drug administration will be blinded.
Treatment groups
770 Participants
are divided into 3 treatment groupsGroup A: LevetiracetamActive comparator 1 intervention
Group B: Levetiracetam + low dose KetamineExperimental treatment 1 intervention
Group C: Levetiracetam + high dose KetamineExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Termination of SE
Termination of SE from 15 minutes after starting the study drug infusion, sustained for 60 minutes without using additional anti-seizure medication. Termination of SE is determined by (1) improving consciousness and absence of clinically apparent seizures at 60 minutes or (2) absence of any electrographic status epilepticus (ESE) after 15 minutes in those with EEG monitoring and no improvement in consciousness.
Time frame
From 15 minutes after starting the study drug infusion, sustained for 60 minutes without using additional anti-seizure medication.Secondary outcomes
1
Desirability of response (DOOR) outcome
One secondary outcome will be a desirability of response (DOOR) outcome which is a composite efficacy measure evaluated on a graded scale from 1 to 5 at 60 minutes, as follows: * No clinically evident or electrographic seizures after 15 minutes, no rescue drugs, and improving mental status by 60 minutes * No clinically evident or electrographic seizures after 15 minutes, not intubated, but not improving mental status at 60 minutes * No clinically evident or electrographic seizures after 15 minutes, but intubated or use of additional seizures medications (including medications used for intubation) * Any clinically evident seizure or electrographic seizure requiring rescue medicine within the timeframe between 15 and 60 minutes * Life-threatening hypotension or cardiac arrhythmia or death within 60 minutes The Central Adjudication Core will determine the DOOR grade (1-5) based on clinical outcome data provided by the site and EEG data provided by the Central EEG Core.
Time frame
60 minutes after starting the study drug infusion2
Endotracheal intubation
Endotracheal intubation within 60 minutes of randomization (start of study drug infusion) and duration
Time frame
Within 60 minutes after start of the study drug infusion3
ICU duration
ICU duration during the study period for those that are admitted to the ICU as abstracted from the hospital admission record
Time frame
Up to 30 days after enrollment4
Hospital length-of-stay (LOS)
Hospital length-of-stay (LOS) from the ED as abstracted from the hospital admission record
Time frame
Up to 30 days after enrollmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Virginia
Lead sponsor
University of Michigan
Collaborator
Medical University of South Carolina
Collaborator
Massachusetts General Hospital
Collaborator
Children's National Research Institute
Collaborator
Source ClinicalTrials.gov