Status Epilepticus
Conditions
Keywords
Status epilepticus, Refractory status epilepticus, Generalized convulsive status epilepticus, Exogenous ketone esters, Children, Seizures
Brief summary
This study aims to investigate the efficacy of add-on exogenous ketone esters for the treatment of children with refractory generalized convulsive status epilepticus
Detailed description
Generalized convulsive status epilepticus (GCSE) is a common neurological emergency in children with significant morbidity and mortality. Benzodiazepines (Bzs) are the initial anti-seizure medications (ASMs) for children with GCSE, but nearly a third of cases are not controlled by (Bzs). Moreover, about 40% of cases not responding to BZs are not controlled by second-line ASMs. Ketogenic diet (KD) has been classically used for treating children with drug resistant epilepsy. Recently, KD has been used for refractory and super refractory status epilepticus. However, KD takes time to achieve ketosis and may be practically challenging in emergency situations and critically ill patients. Exogenous ketone esters (EKE) could be a more convenient and rapid way to achieve ketosis in acute settings.
Interventions
500 mg/kg over 5 min administered by nasogastric tube, followed after 1 hr by repeated hourly doses of 125 mg/kg for 8 hrs.
Sponsors
Sohag University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Eligible children will be randomized into two equal-sized groups. Study group: will receive exogenous ketone esters plus standard of care. Control group: will receive only standard of care.
Eligibility
Sex/Gender
ALL
Age
1 Years to 10 Years
Healthy volunteers
No
Inclusion criteria
* Refractory Generalized convulsive status epilepticus.
Exclusion criteria
* 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. * Hypo-/hyperglycemia. * Metabolic acidosis. * Ketosis (βHB \> 2 mmol/L). * Associated severe disease condition, including hepatic, renal, respiratory, cardiac, gastrointestinal, endocrinal, and immune systems. * Malnutrition/obesity. * Limitations to nasogastric tube feeding. * Inborn errors of metabolism. * Allergies or any other contraindication to exogenous ketone esters. * Current or recent (within the last 24 hours) propofol therapy. * Intake of carbonic-anhydrase inhibitors.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients achieving electroclinical cessation of seizures | 60 minutes | Proportions of patients who achieve cessation of BOTH clinical seizures (as observed clinically) AND electrical seizures (evaluated by electroencephalography \[EEG\]) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to electroclinical cessation of seizures | 24 hours | Time to cessation of BOTH clinical seizures (as observed clinically) AND electrical seizures (evaluated by electroencephalography \[EEG\]) |
| Proportion of patients achieving electroclinical seizure freedom | 24 hours | Proportion of patients achieving freedom from BOTH clinical seizures (as observed clinically) AND electrical seizures (evaluated by electroencephalography \[EEG\]) |
| Proportion of patients with super-refractory status epilepticus | 24 hours | 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 |
| Proportion of patients achieving electroclinical cessation of seizures | 12 hours | Proportions of patients who achieve cessation of BOTH clinical seizures (as observed clinically) AND electrical seizures (evaluated by electroencephalography \[EEG\]) |
| Change in blood beta-hydroxybutyrate level | From baseline to 30 minutes, 1 hour, 2 hours, 5 hours, 9 hours, and 12 hours study timepoints | Change in blood level of beta-hydroxybutyrate |
| Change in blood glucose level | From baseline to 30 minutes, 1 hour, 2 hours, 5 hours, 9 hours, and 12 hours study timepoints | Change in blood level of glucose |
| Change in blood pH | From baseline to 30 minutes, 1 hour, 2 hours, 5 hours, 9 hours, and 12 hours study timepoints | Change in blood pH |
| Proportion of patients with adverse gastrointestinal effects | 24 hours | Proportion of patients with adverse gastrointestinal effects (vomiting, diarrhea, abdominal pain) evaluated by direct observation and patient-reporting |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in blood alanine transaminase level | From baseline to 1 hour and 12 hours study timepoints | Change in blood alanine transaminase (ALT) level |
| Change in blood bicarbonates level | From baseline to 30 minutes, 1 hour, 2 hours, 5 hours, 9 hours, and 12 hours study timepoints | Change in blood bicarbonates level |
| Change in serum creatinine level | From baseline to 1 hour and 12 hours study timepoints | Change in serum creatinine level |
| Change in blood lactate level | From baseline to 30 minutes, 1 hour, 2 hours, 5 hours, 9 hours, and 12 hours study timepoints | Change in blood lactate level |
| Change in hemoglobin level | From baseline to 1 hour and 12 hours study timepoints | Change in hemoglobin level |
| Change in leukocyte count | From baseline to 1 hour and 12 hours study timepoints | Change in leukocyte count |
| Change in platelets count | From baseline to 1 hour and 12 hours study timepoints | Change in platelets count |
| Change in serum sodium level | From baseline to 1 hour and 12 hours study timepoints | Change in serum sodium level |
| Change in serum potassium level | From baseline to 1 hour and 12 hours study timepoints | Change in serum potassium level |
| Change in CRP level | From baseline to 1 hour and 12 hours study timepoints | Change in CRP level |
| Change in lipid profile | From baseline to 1 hour and 12 hours study timepoints | Change in lipid profile |
Countries
Egypt
Contacts
Primary ContactElsayed M Abdelkreem, MD, PhD
Outcome results
None listed