Status:
COMPLETED
Ketogenic Diet for Refractory Status Epilepticus
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
Mayo Clinic
Queen's Medical Center
Conditions:
Status Epilepticus
Seizure
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
This research is being done to observe the safety, tolerability, side effects, and effectiveness of the ketogenic diet in people with continuous seizures (status epilepticus) being treated in a neuroi...
Eligibility Criteria
Inclusion
- Patients 18 years and older in refractory status epilepticus (continuous or recurrent seizures without return to baseline mental status between seizures, lasting \> 30 minutes) placed on anesthetics/sedating agents (barbiturates or benzodiazepines) after at least one first- and second-line agent failed to control seizures, and with clinical and/or electrographic seizures following attempt to wean anesthetic/sedating agents after 24 hours.
Exclusion
- Unstable metabolic condition
- Hemodynamic or cardiorespiratory instability
- Coagulopathy
- Liver failure
- Total cholesterol \> 300 mg/dL
- Inability to tolerate enteral feeds, including ileus
- Pregnancy
- Family refusal/no consent
- Received any propofol infusions within 24 hours
- Known fatty acid oxidation disorder or pyruvate carboxylase deficiency
Key Trial Info
Start Date :
November 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2017
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT01796574
Start Date
November 1 2012
End Date
March 1 2017
Last Update
March 14 2017
Active Locations (9)
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1
Mayo Clinic
Phoenix, Arizona, United States, 85054
2
Queen's Medical Center
Honolulu, Hawaii, United States, 96813
3
Rush University Medical Center
Chicago, Illinois, United States, 60612
4
Johns Hopkins University
Baltimore, Maryland, United States, 21287