Actively Recruiting
Ketamine add-on Therapy for Established Status Epilepticus Treatment Trial (KESETT)
Led by University of Virginia · Updated on 2026-05-14
770
Participants Needed
52
Research Sites
26 weeks
Total Duration
On this page
Sponsors
U
University of Virginia
Lead Sponsor
U
University of Michigan
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating if adding ketamine to levetiracetam treatment can better control status epilepticus (SE) in patients whose seizures do not respond to benzodiazepines. This phase 3, multicenter, randomized, and blinded study compares two doses of ketamine combined with levetiracetam against levetiracetam alone. The study aims to find out which treatment stops SE more effectively and to assess safety, especially in children. Participants are randomly assigned to receive one of three treatments: levetiracetam alone at 60 mg/kg, levetiracetam plus a low dose of ketamine (1 mg/kg), or levetiracetam plus a higher dose of ketamine (3 mg/kg). The study drugs are produced centrally and administered via infusion with identical methods to maintain blinding. The trial initially enrolls up to 350 participants evenly across groups before shifting to adaptive randomization, with a total maximum enrollment of 770. During the study, researchers monitor seizure termination starting 15 minutes after infusion and sustained for 60 minutes without additional anti-seizure drugs. They assess consciousness improvement, EEG seizure activity, and safety outcomes including need for intubation, ICU and hospital stay duration, late recurrent seizures, and mortality up to 30 days. Participants undergo close clinical observation and EEG when available to evaluate treatment effects and adverse events throughout the trial period.
CONDITIONS
Brief Title
Ketamine add-on Therapy for Established Status Epilepticus Treatment Trial (KESETT)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- The patient was witnessed to have a convulsive seizure lasting more than 5 minutes
- The patient received an adequate dose of benzodiazepines, which may be divided
- The last benzodiazepine dose was given 5 to 30 minutes before study drug administration
- Continued or recurring seizures in the Emergency Department
- Age 1 year or older
- Known or estimated weight of 10 kilograms or more
You will not qualify if you...
- Known pregnancy
- Prisoner status
- Previously enrolled in KESETT or opted out
- Treatment with second-line anticonvulsants for this seizure episode
- Treatment with sedatives with anticonvulsant properties other than benzodiazepines for this seizure episode
- Endotracheal intubation before enrollment
- Acute traumatic brain injury before seizures
- Scalp injury or burn preventing EEG placement
- Known allergy or contraindication to ketamine or levetiracetam
- Low blood sugar below 50 mg/dL
- High blood sugar above 400 mg/dL
- Cardiac arrest or post-anoxic seizures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From infusion start until 60 minutes after infusion
Participants receive study drug infusions of levetiracetam alone or combined with low or high dose ketamine to treat status epilepticus.
1 treatment infusion visit
Duration - Up to 30 days after enrollment
Participants are monitored for safety outcomes, seizure recurrence, and hospital course up to 30 days after enrollment.
Visits as needed during hospital stay up to 30 days
Trial Site Locations
Total: 52 locations
1
Banner University Medical Center - Tucson Campus
Tucson, Arizona, United States, 85724
Actively Recruiting
2
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States, 90024
Not Yet Recruiting
3
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027
Not Yet Recruiting
4
Stanford University Medical Center
Palo Alto, California, United States, 94304
Not Yet Recruiting
5
UC Davis Medical Center
Sacramento, California, United States, 95817
Actively Recruiting
6
San Francisco General Hospital
San Francisco, California, United States, 94143
Not Yet Recruiting
7
UCSF Medical Center
San Francisco, California, United States, 94143
Not Yet Recruiting
8
Yale New Haven Hospital
New Haven, Connecticut, United States, 06519
Actively Recruiting
9
Christiana Hospital
Newark, Delaware, United States, 19718
Not Yet Recruiting
10
Nemours Children's Hospital
Wilmington, Delaware, United States, 19803
Not Yet Recruiting
11
Children's National Medical Center
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
12
Orlando Regional Medical Center
Orlando, Florida, United States, 32806
Not Yet Recruiting
13
Grady Memorial Hospital
Atlanta, Georgia, United States, 30303
Actively Recruiting
14
Arthur M. Blank Hospital
Atlanta, Georgia, United States, 30329
Actively Recruiting
15
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
Not Yet Recruiting
16
Comer Children's Hospital
Chicago, Illinois, United States, 60637
Not Yet Recruiting
17
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
Not Yet Recruiting
18
IU Health Methodist Hospital
Indianapolis, Indiana, United States, 46202
Not Yet Recruiting
19
Riley Hospital for Children
Indianapolis, Indiana, United States, 46202
Not Yet Recruiting
20
University of Iowa Medical Center
Iowa City, Iowa, United States, 52242
Not Yet Recruiting
21
University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
Not Yet Recruiting
22
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Not Yet Recruiting
23
University of Michigan University Hospital
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
24
Detroit Receiving Hospital
Detroit, Michigan, United States, 48201
Not Yet Recruiting
25
Sinai-Grace Hospital
Detroit, Michigan, United States, 48201
Not Yet Recruiting
26
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Not Yet Recruiting
27
University of Minnesota Masonic Children's Hospital
Minneapolis, Minnesota, United States, 55414
Not Yet Recruiting
28
Hennepin County Medical Center
Minneapolis, Minnesota, United States, 55415
Not Yet Recruiting
29
University of Minnesota Medical Center
Minneapolis, Minnesota, United States, 55455
Not Yet Recruiting
30
SUNY Upstate Medical University
Syracuse, New York, United States, 13210
Not Yet Recruiting
31
Duke Regional Hospital
Durham, North Carolina, United States, 27710
Not Yet Recruiting
32
Duke University Hospital
Durham, North Carolina, United States, 27710
Not Yet Recruiting
33
University of Cincinnati Medical Center
Cincinnati, Ohio, United States, 45267
Not Yet Recruiting
34
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Actively Recruiting
35
OSU Wexner Medical Center
Columbus, Ohio, United States, 43210
Not Yet Recruiting
36
Oregon Health & Science University Hospital
Portland, Oregon, United States, 97239
Actively Recruiting
37
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Not Yet Recruiting
38
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, United States, 19104
Not Yet Recruiting
39
Temple University Hospital
Philadelphia, Pennsylvania, United States, 19140
Actively Recruiting
40
Jefferson Einstein Philadelphia Hospital
Philadelphia, Pennsylvania, United States, 19141
Not Yet Recruiting
41
UPMC Presbyterian Hospital
Pittsburgh, Pennsylvania, United States, 15213
Not Yet Recruiting
42
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15224
Actively Recruiting
43
Reading Hospital
West Reading, Pennsylvania, United States, 19611
Actively Recruiting
44
Children's Medical Center Dallas
Dallas, Texas, United States, 75235
Not Yet Recruiting
45
Memorial Hermann Texas Medical Center
Houston, Texas, United States, 77030
Actively Recruiting
46
Primary Children's Hospital
Salt Lake City, Utah, United States, 84108
Not Yet Recruiting
47
University of Utah Healthcare
Salt Lake City, Utah, United States, 84112
Not Yet Recruiting
48
University of Virginia Medical Center
Charlottesville, Virginia, United States, 22908
Actively Recruiting
49
VCU Medical Center
Richmond, Virginia, United States, 23298
Not Yet Recruiting
50
Harborview Medical Center
Seattle, Washington, United States, 98104
Actively Recruiting
51
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Not Yet Recruiting
52
Froedtert Hospital
Milwaukee, Wisconsin, United States, 53226
Not Yet Recruiting
Research Team
M
Megan Wardius
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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