Clinical Research Directory
Browse clinical research sites, groups, and studies.
Ketamine add-on Therapy for Established Status Epilepticus Treatment Trial (KESETT)
Sponsor: University of Virginia
Summary
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.
Key Details
Gender
All
Age Range
1 Year - Any
Study Type
INTERVENTIONAL
Enrollment
770
Start Date
2026-03-06
Completion Date
2029-12
Last Updated
2026-04-09
Healthy Volunteers
No
Conditions
Interventions
Levetiracetam (LEV) (60 mg/Kg) + 1 mg/kg Ketamine (KET)
The 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)
The 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)
The 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.
Locations (47)
Banner University Medical Center - Tucson Campus
Tucson, Arizona, United States
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States
Children's Hospital Los Angeles
Los Angeles, California, United States
UC Davis Medical Center
Sacramento, California, United States
San Francisco General Hospital
San Francisco, California, United States
Yale New Haven Hospital
New Haven, Connecticut, United States
Christiana Hospital
Newark, Delaware, United States
Nemours Children's Hospital
Wilmington, Delaware, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
Orlando Regional Medical Center
Orlando, Florida, United States
Grady Memorial Hospital
Atlanta, Georgia, United States
Arthur M. Blank Hospital
Atlanta, Georgia, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
Comer Children's Hospital
Chicago, Illinois, United States
University of Chicago Medical Center
Chicago, Illinois, United States
IU Health Methodist Hospital
Indianapolis, Indiana, United States
Riley Hospital for Children
Indianapolis, Indiana, United States
University of Iowa Medical Center
Iowa City, Iowa, United States
University of Maryland Medical Center
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
University of Michigan University Hospital
Ann Arbor, Michigan, United States
Detroit Receiving Hospital
Detroit, Michigan, United States
Henry Ford Hospital
Detroit, Michigan, United States
University of Minnesota Masonic Children's Hospital
Minneapolis, Minnesota, United States
Hennepin County Medical Center
Minneapolis, Minnesota, United States
University of Minnesota Medical Center
Minneapolis, Minnesota, United States
SUNY Upstate Medical University
Syracuse, New York, United States
Duke Regional Hospital
Durham, North Carolina, United States
Duke University Hospital
Durham, North Carolina, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
Oregon Health & Science University Hospital
Portland, Oregon, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Temple University Hospital
Philadelphia, Pennsylvania, United States
Jefferson Einstein Philadelphia Hospital
Philadelphia, Pennsylvania, United States
UPMC Presbyterian Hospital
Pittsburgh, Pennsylvania, United States
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
Reading Hospital
West Reading, Pennsylvania, United States
Children's Medical Center Dallas
Dallas, Texas, United States
Memorial Hermann Texas Medical Center
Houston, Texas, United States
Primary Children's Hospital
Salt Lake City, Utah, United States
University of Utah Healthcare
Salt Lake City, Utah, United States
University of Virginia Medical Center
Charlottesville, Virginia, United States
VCU Medical Center
Richmond, Virginia, United States
Harborview Medical Center
Seattle, Washington, United States
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States
Froedtert Hospital
Milwaukee, Wisconsin, United States