BridgeMD
New treatment option for Super-refractory Status Epilepticus
Official title KD Treatment for Super-refractory Status Epilepticus
ClinicalTrials.gov ID: NCT07496749
What this study is testing
What is Standard Medical Therapy?
Standard Medical Therapy is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for super-refractory status epilepticus.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 14 to 80
You may be able to join if
- Patients diagnosed with super-refractory status epilepticus (SRSE), in whom status epilepticus (SE) persists or recurs after the initial treatment...
- Age between 14 and 80 years, regardless of gender.
- The patient's legal guardian has provided signed informed consent.
You likely can't join if
- Patients with lipid metabolism disorders, including defects in fatty acid transport and beta-oxidation, such as carnitine deficiency (primary) and...
- 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...
- Pancreatitis.
See the full eligibility 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...
- Age between 14 and 80 years, regardless of gender.
- The patient's legal guardian has provided signed informed consent.
- 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...
- 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 μmol/L]).
- Pancreatitis.
- Pregnancy.
- Metabolic instability (blood glucose \ 160 mmol/L).
- Septic shock.
- Complicated by diabetes insipidus.
- Status epilepticus caused by hypoxic-ischemic brain injury.
The study team makes the final eligibility decision.
Where it's taking place
- Hefei, Anhui, China
- Beijing, Beijing Municipality, China
- Fuzhou, Fujian, China
- Nanning, Guangxi, China
- Guiyang, Guizhou, China
- Haikou, Hainan, China
- Shijiazhuang, Hebei, China
- Harbin, Heilongjiang, China
- Chifeng, Neimenggu, China
- Jinan, Shandong, China
- Hanzhou, Zhejiang, China
- Beijing, China
- Jilin City, China
- Liaocheng, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 14 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hefei, Anhui, China; Beijing, Beijing Municipality, China; Fuzhou, Fujian, China; Nanning, Guangxi, China; Guiyang, Guizhou, China; Haikou, Hainan, China and 8 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.