Actively Recruiting

Phase 3
Age: 1Year +
All Genders
NCT06907173

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

195 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

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.

CONDITIONS

Official Title

Ketamine add-on Therapy for Established Status Epilepticus Treatment Trial (KESETT)

Who Can Participate

Age: 1Year +
All Genders

Eligibility Criteria

Eligible

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 dose of benzodiazepine 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 at least 10 kilograms
Not Eligible

You will not qualify if you...

  • Known pregnancy
  • Prisoner status
  • Opt-out identification or prior enrollment in KESETT
  • Treatment with second line anticonvulsants (fosphenytoin, phenytoin, valproic acid, levetiracetam, phenobarbital, or others) for this seizure episode
  • Treatment with sedatives with anticonvulsant properties other than benzodiazepines (e.g., propofol, etomidate, ketamine) for this seizure episode
  • Endotracheal intubation before enrollment
  • Acute traumatic brain injury occurring before seizures
  • Scalp injury or burn preventing EEG placement
  • Known allergy or contraindication to ketamine or levetiracetam
  • Low blood sugar (less than 50 mg/dL)
  • High blood sugar (more than 400 mg/dL)
  • Cardiac arrest or seizures after lack of oxygen

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

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Research Team

M

Megan Wardius

CONTACT

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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