Butylphthalide's Safety and Efficacy for Improving Neurological Function Prognosis in Pati
Butylphthalide (NBP) is a neuroprotective medication capable of ameliorating neurological dysfunction induced by ischemia, hypoxia, and reperfusion injury in the brain. However, evidence regarding the improvement of neurological function prognosis in patients with return of spontaneous circulation (ROSC) after cardiac
| Condition(s) | Butylphthalide, Cardiac Arrest, Neuroprotective Drugs |
|---|---|
| Status | Recruiting |
| Phase | Phase 4 |
| Study type | Interventional |
| Summary | Butylphthalide (NBP) is a neuroprotective medication capable of ameliorating neurological dysfunction induced by ischemia, hypoxia, and reperfusion injury in the brain. However, evidence regarding the improvement of neurological function prognosis in patients with return of spontaneous circulation (ROSC) after cardiac arrest (CA) by NBP is limited. This study aims to evaluate the safety and efficacy of NBP treatment in improving the neurological function prognosis of patients with ROSC after CA.The study will be a single-center, randomized, double-blind, placebo-controlled trial. The sample size is estimated to be 100 patients. Eligible patients will be randomly allocated in a 1:1 ratio to receive either NBP or placebo treatment daily for a duration of 14 days. The initial administration o |
| Who can participate | Inclusion Criteria: 1. Age 18-80 years old. 2. GCS scores ≤8 upon admission. 3. ROSC ≥30min. 4. Signed the informed consent form. Exclusion Criteria: 1. Cardiac arrest due to irreversible causes such as trauma, poisoning, etc. 2. Cardiac arrest due to end-stage conditions such as advanced cancer. 3. Persistent cardiogenic shock that is unreversed (defined as a systolic blood pressure persistently \<90mmHg despite treatment with fluid resuscitation, vasopressor agents, and inotropic medications). 4. Presence of pre-existing cerebrovascular disease prior to cardiac arrest or confirmed intracranial hemorrhage by CT scan following admission. 5. Pre-existing CPC scores of 3-5 prior to cardiac arrest. 6. Prior use of NBP or any medication containing NBP before cardiac arrest. 7. Presence of seve |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Lead sponsor | Tang Ziren |
| Locations | Beijing, Beijing Municipality, China |
| Start date | 2021-09-01 |
| NCT ID | NCT06353334 |
| Official listing | https://clinicaltrials.gov/study/NCT06353334 |