Exogenous Ketone Esters for Refractory Status Epileptics
ConditionStatus Epilepticus
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age1-10
SponsorSohag University
About this trial
This study aims to investigate the efficacy of add-on exogenous ketone esters for the treatment of children with refractory generalized convulsive status epilepticus
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Refractory Generalized convulsive status epilepticus.
Disqualifiers
Failure to obtain informed consent.
Recent intake of exogenous ketones, ketogenic diet, or any dietary restrictions/modifications.
Hemodynamic or cardio-respiratory instability.
Traumatic brain injury.
Trial design
Design model
Parallel
Treatments tested in this trial
Exogenous ketone ester
Drug500 mg/kg over 5 min administered by nasogastric tube, followed after 1 hr by repeated hourly doses of 125 mg/kg for 8 hrs.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Study groupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Proportion of patients achieving electroclinical cessation of seizures
Proportions of patients who achieve cessation of BOTH clinical seizures (as observed clinically) AND electrical seizures (evaluated by electroencephalography \[EEG\])
Time frame
60 minutesSecondary outcomes
1
Proportion of patients achieving electroclinical cessation of seizures
Proportions of patients who achieve cessation of BOTH clinical seizures (as observed clinically) AND electrical seizures (evaluated by electroencephalography \[EEG\])
Time frame
12 hours2
Time to electroclinical cessation of seizures
Time to cessation of BOTH clinical seizures (as observed clinically) AND electrical seizures (evaluated by electroencephalography \[EEG\])
Time frame
24 hours3
Proportion of patients achieving electroclinical seizure freedom
Proportion of patients achieving freedom from BOTH clinical seizures (as observed clinically) AND electrical seizures (evaluated by electroencephalography \[EEG\])
Time frame
24 hours4
Proportion of patients with super-refractory status epilepticus
Proportion of patients with persistent seizures for 24 hours or more after initiation of 3rd line medications (anesthetics) or recurrence of seizure during withdrawal of the anesthetics
Time frame
24 hoursOther outcomes
1
Change in blood bicarbonates level
Change in blood bicarbonates level
Time frame
From baseline to 30 minutes, 1 hour, 2 hours, 5 hours, 9 hours, and 12 hours study timepoints2
Change in blood lactate level
Change in blood lactate level
Time frame
From baseline to 30 minutes, 1 hour, 2 hours, 5 hours, 9 hours, and 12 hours study timepoints3
Change in hemoglobin level
Change in hemoglobin level
Time frame
From baseline to 1 hour and 12 hours study timepoints4
Change in leukocyte count
Change in leukocyte count
Time frame
From baseline to 1 hour and 12 hours study timepointsSponsors and contacts
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Source ClinicalTrials.gov