KESETT - Clinical Trial
What is the Purpose of this Study?
When a patient arrives at Duke and qualifies for the study, they will be placed into one of three treatment groups. Some will get only levetiracetam, while others will get levetiracetam with either a low or high dose of ketamine.
The medical team will watch the patient closely and check how they are doing at 15 minutes and 1 hour after the study medicine is given. An monitoring headband device will also be placed on the patient's head to measure brain activity and watch for seizures.
The study team will continue to check on the patient for up to 24 hours, or until the patient leaves the hospital-whichever happens first. Once the patient goes home, their part in the study will be finished.
The KESETT study is a research project that looks at a new way to treat a serious problem called status epilepticus (SE). SE happens when a person has very long or repeated seizures that do not stop. This is very dangerous because it can cause trouble with breathing or hurt the brain if it is not treated quickly.
Who Can Participate in the Study?
Adults 18 or older can join if their seizure lasts more than 5 minutes and does not stop after benzodiazepines. People cannot join if they are pregnant, in prison, wearing a “no research” bracelet, have very high or low blood sugar, or if their heart has stopped.
What is Involved?
The KESETT study is looking at a new way to treat a serious problem called status epilepticus (SE). SE happens when a person has very long or repeated seizures that do not stop. This can be very dangerous because it can cause breathing problems or hurt the brain if it is not treated quickly.
Doctors usually treat SE first with a medicine called benzodiazepines, but these do not work for everyone. When they do not work, doctors use another medicine called levetiracetam, which only helps about half the time. The KESETT study will test if adding another medicine called ketamine to levetiracetam helps more people get better.
When a patient comes to Duke and can join the study, they will be put into one of three groups. One group will get levetiracetam alone. The other two groups will get levetiracetam plus ketamine, either in a low dose or a high dose. Doctors will check the patient 15 minutes and 1 hour after the medicine is given. A special headband will be placed on the patient’s head to watch brain activity and look for seizures. The study team will keep checking on the patient for up to 24 hours or until they leave the hospital. After the patient goes home, their part in the study is done.
Study Details
