A Phase 2/3 interventional study of Traditional Treatment (Group T) and Ketamine Infusion (Group K) in Refractory Epilepsy, sponsored by University of Alabama at Birmingham. Withdrawn at 1 site in United States. Open to participants aged 18 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-05-21.
Sponsored by University of Alabama at Birmingham · Phase 2/3, Interventional, and Prevention
The study will investigate the efficacy of the N-methyl-D-aspartate receptor antagonist ketamine as a first line agent in refractory status epilepticus versus traditional general anesthetic agents used for burst suppression that target the gamma-aminobutyric acid adrenergic receptors.
The traditional treatment for refractory status epilepticus includes diazepam, midazolam, valproic acid, thiopental and propofol. These medications fail to control seizure activity in 20-40% of patients. This is attributed to decrease in activity of gamma-aminobutyric acid receptors along with reciprocal up regulation of N-Methyl-D-aspartate receptors. Glutamate activation of N-methyl-D-aspartate receptors promotes calcium influx and excitotoxicity. Ketamine, an intravenous anesthetic agent which is a non-competitive antagonist of N-methyl-D-aspartate receptors can block the flow of Ca and Na and by combining with phencyclidine binding sites inside the ion channel of N-methyl-D-aspartate receptors, reduce the epileptiform burst discharges and after potential. Therefore, targeting the N-methyl-D-aspartate receptors with ketamine may provide a novel approach to control refractory seizures. Moreover, by blocking glutamate mediated N-methyl-D-aspartate receptor induced neurotoxicity, ketamine may render neuroprotection. Ketamine also provides additional advantage of hemodynamic stability. Currently, ketamine is used as a last resort drug in the treatment of refractory status epilepticus.
The specific aim is to determine whether continuous infusion of ketamine as a first line agent for refractory status epilepticus is effective in controlling seizures.
The central hypothesis of our proposal is that early treatment with ketamine will be much more efficacious in controlling refractory status compared to the traditional treatment.
126 studies on the registry are indexed under Status Epilepticus; 37 are open to participants now.
Browse Status Epilepticus studies →University of Alabama at Birmingham is the lead sponsor of 1,396 studies on the registry; 284 are open to participants now.
Of its 156 completed or terminated interventional studies of FDA-regulated products, 124 (79%) have results posted.
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Exclusion Criteria:
Group T patients will be placed into burst suppression with the traditional drug infusions which include any single or combination of drugs; usually benzodiazepines, barbiturates and or propofol.
Drug: Traditional Treatment (Group T)
Patients in the group K arm will receive a loading dose of 2.5 mg/kg of ketamine followed by a continuous infusion with a starting dose of 3mg/kg/hr with titration in 1mg/kg/hr increments until burst suppression is achieved or a maximum dose of 10mg/kg/hr is reached. After 48 hours of burst suppression the ketamine dosage will be reduced by 2mg/kg/hr in a stepwise fashion to evaluated for EEG or clinical evidence of seizure recurrence.
Drug: Ketamine Infusion (Group K)
Patients will receive traditional drug infusions
Also known as: benzodiazepines, barbiturates, propofol
Patients will receive loading dose of 2.5 mg/kg of ketamine followed by a continuous infusion with a starting dose of 3mg/kg/hr with titration in 1mg/kg/hr increments until burst suppression is achieved or a maximum dose of 10mg/kg/hr is reached
Also known as: Ketalar
Time taken for burst suppression
Average time for burst suppression
Time frame: Baseline to 1 hr
Time taken for termination of seizures
Average time for seizures to terminate
Time frame: Baseline to 24 hrs
Use of vasopressors
The need of vasopressors
Time frame: baseline to 72 hrs
Number of days on ventilator
Total number of days patient is on the ventilator
Time frame: Baseline to 72 hrs
Length of stay in ICU
Total number of days in the ICU
Time frame: Baseline to 72 hrs postoperatively
Use of parenteral or enteral nutrition
Nutrition provided through a feeding tube or catheter
Time frame: Baseline to 72 hrs postoperatively
Medical imaging results
MRI scans 7 to 10 days after burst suppression
Time frame: Post-op Day 2 to Post-op day 10
Mortality
death
Time frame: baseline to post-op day 10
Plan to share: No
This study is withdrawn, as verified in May 2021. You cannot join it, but the record below documents what was studied.
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University of Alabama at Birmingham