Efficacy of Exogenous Ketone Esters for Children With Refractory Convulsive Status Epileptics
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Proportion of patients achieving electroclinical cessation of seizures
研究概览
简要总结
This study aims to investigate the efficacy of add-on exogenous ketone esters for the treatment of children with refractory generalized convulsive status epilepticus
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Refractory Generalized convulsive status epilepticus.
排除标准
- •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.
研究组 & 干预措施
Study group
Children receiving exogenous ketone esters + standard of care
干预措施: Exogenous ketone ester (Drug)
结局指标
主要结局
Proportion of patients achieving electroclinical cessation of seizures
时间窗: 60 minutes
Proportions of patients who achieve cessation of BOTH clinical seizures (as observed clinically) AND electrical seizures (evaluated by electroencephalography \[EEG\])
次要结局
- Proportion of patients achieving electroclinical cessation of seizures(12 hours)
- Time to electroclinical cessation of seizures(24 hours)
- Proportion of patients achieving electroclinical seizure freedom(24 hours)
- Proportion of patients with super-refractory status epilepticus(24 hours)
- Proportion of patients with adverse gastrointestinal effects(24 hours)
- 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 glucose level(From baseline to 30 minutes, 1 hour, 2 hours, 5 hours, 9 hours, and 12 hours study timepoints)
- Change in blood pH(From baseline to 30 minutes, 1 hour, 2 hours, 5 hours, 9 hours, and 12 hours study timepoints)
研究者
Elsayed Abdelkreem
Lecturer of Pediatrics
Sohag University