Baylor College of Medicine, Texas Children's Hospital study will look at best treatment for prolonged seizures
HOUSTON - Oct. 1, 2015 - A study to determine which of three drugs commonly used to treat a condition called status epilepticus is most effective begins this month under the direction of Baylor College of Medicine and Texas Children's Hospitalpediatric emergency medicine physicians. Status epilepticus means prolonged seizures that are not controlled by usual treatment with drugs called benzodiazepines.
Patients coming into the Texas Children's Hospital emergency center with prolonged seizures that are not controlled after a full dose of benzodiazepines will be enrolled in the emergency research under a special emergency protocol that does not require immediate informed consent.
The study is part of the Established Status Epilepticus Treatment Trial, a multi-center network funded by the National Institute of Neurological Disorders and Stroke.
"There are no definitive studies that show which treatment is most effective in stopping status epilepticus or prolonged seizure episodes," said Dr. Daniel Rubalcava, assistant professor of pediatrics - emergency medicine at Baylor and Texas Children's Hospital, and the principal investigator for this study at Baylor/Texas Children's.
Status epilepticus is a life-threatening condition defined as a seizure lasting longer than five minutes that does not stop on its own and from which the patient does not wake.
All patients who come to the emergency department with this condition will receive a benzodiazepine first. Benzodiazepines, usually prescribed short-term for anxiety and insomnia, are used in the treatment of status epilepticus.
If the seizure does not resolve, doctors will give them one of the three medications. Later, they will study the effects of the medicine to determine which of the three is most effective and safe in treating status epilepticus.
All three drugs in the study are commonly used in emergency medicine departments and approved by the U.S. Food and Drug Administration. They include phenytoin (fPHT), valproic acid (VPA), and levetiracetam (LVT).
Because a patient having a seizure that will not stop cannot give consent at the time he or she is enrolled in the study and because the unending seizure must be treated quickly, there is often not enough time to obtain consent from his or her mother, father or guardian, particularly if that person is not present at the hospital. For that reason, the patient may be enrolled in the study without the health care giver obtaining such consent.
These are frequently called emergency studies and are approved under federal rules that govern research. As soon as a parent or guardian (legal representative) is located, that person will be asked to give permission for the patient to continue in the study. (All patients will be 17 or under and must have a legal representative to give consent for the study to continue.)
The Baylor/Texas Children's site is one of three study sites in Houston including Memorial Hermann and Lyndon Baines Johnson Hospital.
About Texas Children’s Hospital
Texas Children’s Hospital, a not-for-profit health care organization, is committed to creating a healthier future for children and women throughout the global community by leading in patient care, education and research. Consistently ranked as the best children’s hospital in Texas, and among the top in the nation, Texas Children’s has garnered widespread recognition for its expertise and breakthroughs in pediatric and women’s health. The hospital includes the Jan and Dan Duncan Neurological Research Institute; the Feigin Center for pediatric research; Texas Children’s Pavilion for Women, a comprehensive obstetrics/gynecology facility focusing on high-risk births; Texas Children’s Hospital West Campus, a community hospital in suburban West Houston; and Texas Children’s Hospital The Woodlands, a second community hospital planned to open in 2017. The organization also created the nation’s first HMO for children, has the largest pediatric primary care network in the country and a global health program that’s channeling care to children and women all over the world. Texas Children’s Hospital is affiliated with Baylor College of Medicine. For more information, go to www.texaschildrens.org. Get the latest news by visiting the online newsroom and Twitter at twitter.com/texaschildrens.