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KD Treatment for Super-refractory Status Epilepticus

RecruitingNAAges 14 Years - 80 YearsAllXuanwu Hospital, Beijing
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In plain words

What the trial is, and whether it could suit you

The purpose of the study is to investigate to evaluate the efficacy and safety of ketogenic diet (KD) as an adjunctive therapy in patients with Super Refractory Status Epilepticus (SRSE) in the intensive care unit (ICU).

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Patients diagnosed with super-refractory status epilepticus (SRSE), in whom status epilepticus (SE) persists or recurs after the initial treatment for SE-including intravenous benzodiazepines, an anti-seizure medication (ASM, such as valproate, levetiracetam, or phenobarbital), and an anesthetic (e.g., propofol) administered continuously for 24 hours-fails to terminate the episode, or when SE recurs upon reduction of the anesthetic. * Age between 14 and 80 years, regardless of gender. * The patient's legal guardian has provided signed informed consent. Exclusion Criteria: * Patients with lipid metabolism disorders, including defects in fatty acid transport and beta-oxidation, such as carnitine deficiency (primary) and carnitine-related enzyme deficiencies (including carnitine palmitoyltransferase \[CPT\] I and II deficiency, carnitine translocase deficiency), fatty acid oxidation disorders (including beta-oxidation defects), short-chain acyl-CoA dehydrogenase deficiency (SCAD), medium-chain acyl-CoA dehydrogenase deficiency (MCAD), long-chain acyl-CoA dehydrogenase deficiency (LCAD), long-chain 3-hydroxyacyl-CoA dehydrogenase deficiency, medium-chain 3-hydroxyacyl-CoA dehydrogenase deficiency, pyruvate carboxylase deficiency, and porphyria. * Intolerance to enteral feeding (e.g., intestinal obstruction). * Receipt of propofol infusion within 24 hours. * Hemodynamic instability (systolic blood pressure \<90 mmHg or diastolic blood pressure \<60 mmHg, requiring high-dose vasopressors for maintenance). * Liver failure (aspartate aminotransferase \[AST\], alanine aminotransferase \[ALT\], blood ammonia \>5 times the upper limit of normal; total bilirubin \>10 mg/dL \[171 ฮผmol/L\]). * Pancreatitis. * Pregnancy. * Metabolic instability (blood glucose \<3.1 mmol/L, arterial blood pH \<7.2, serum sodium \<120 or \>160 mmol/L). * Septic shock. * Complicated by diabetes insipidus. * Status epilepticus caused by hypoxic-ischemic brain injury.
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What it tests

  • the ketogenic diet
  • Standard Medical Therapy
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Where

14 sites
The First Affiliated Hospital of Anhui Medical University
Hefei, China
Department of Neurology, Xuanwu Hospital Capital Medical University
Beijing, China
Fujian Medical University Union Hospital
Fuzhou, China
The First Affiliated Hospital of Guangxi Medical University
Nanning, China
Guizhou Provincial People's Hospital
Guiyang, China
The Second Affiliated Hospital of Hainan Medical University
Haikou, China
The First Hospital of Hebei Medical University
Shijiazhuang, China
The First Affiliated Hospital of Harbin Medical University
Harbin, China

โ€ฆand 6 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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