KESETT Start up Site Survey
Congratulations! The KESETT grant is expected to be awarded in January 2025. This purpose of this survey is to confirm your interest in being a site and update your information if you previously expressed interest and provided a letter of support. We are also using this survey to collect information from sites that did not previously express interest, or that provided a letter too late to be included the first time around, but that are now interested in being a replacement or add on site.
This survey will ask for the names and emails of an emergency medicine investigator and a neurology investigator at your site, a study coordinator contact (if you have one), a contracts or administrative contact, and an IT contact that will be involved with implementation of rapid EEG for research. We intend to start up the trial as quickly as possible, and plan to incentivize rapid site start up. Please complete this survey by January 10, 2025.
Here is link to a list of sites that provided LOS and were included in the grant submission. However, your site may not be on this list if you told us of your interest and provided a LOS too late to be included in the submission.
Ketamine in Established Status Epilepticus Treatment Trial (KESETT) Summary
KESETT is a proposed prospective randomized controlled adaptive dose-selection clinical trial to determine the efficacy of adding ketamine to levetiracetam in patients with benzodiazepine refractory status epilepticus in the emergency department. Ketamine has potent anti-seizure properties in preclinical models and in observational clinical studies, is familiar to emergency physicians and widely used for other indication, and of great interest to the status epilepticus community. The trial will enroll a patient population of adults and children similar to those enrolled in the previous ESETT trial, and integration of the trial into emergency care will be implemented in a similar way. KESETT however adds an early EEG outcome. KESETT, like ESETT, is an exception from informed consent (EFIC) trial, and will involve sites conducting community consultation and public disclosure activities, but this time with a single central IRB per NIH policy. We are looking primarily to engage former ESETT sites, SIREN sites, and PECARN sites, but will consider other well qualified sites as well. We initially anticipate 60 trial sites, but will consider adding sites as resources permit. Sites listed in the grant application will have priority for participation in the trial.
A clinical trial synopsis with more detail is available by clicking here.
Please respond to this survey by January 10, 2025.