Neuroprotective Effect of Butylphthalide for Cardiac Arrest Patients

Launched by TANG ZIREN · Aug 25, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating the potential benefits of a drug called Butylphthalide for patients who have experienced a cardiac arrest. Cardiac arrest is a serious condition where the heart stops beating, and it can lead to severe brain damage or even death. The researchers want to see if Butylphthalide can help improve brain function in patients who have survived this critical event, as it has shown promise in helping recovery for other types of brain injuries, like strokes.

To participate in this trial, individuals must be between 18 and 80 years old and have a low Glasgow Coma Scale score (a measure of consciousness) when they arrive at the hospital. They should also have had their heart successfully restarted for at least 30 minutes. However, some people may not be eligible, such as those with certain medical conditions or who have experienced cardiac arrest for irreversible reasons. If eligible, participants can expect to receive the medication and be closely monitored to assess any improvements in their brain function over time. This study aims to find new ways to help patients recover better after a cardiac arrest.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age 18-80 years old.
• • 2. Glasgow Coma Scale (GCS) scores ≤8 upon admission.
• • 3. Return of Spontaneous Circulation (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 severe hepatic or renal dysfunction before cardiac arrest (defined as ≥3× upper limit of normal alanine transaminase or ≥2× upper limit of normal creatinine).
• • 8. Bradycardia or sick sinus syndrome occurs after ROSC.
• • 9. History of prior drug or food allergies, or known allergies to the medication components used in this study.
• • 10. Existence of treatment limitations (patient or their legal representative refusing advanced life support treatment, including mechanical ventilation, chest compressions, targeted temperature management, etc.).
• • 11. Presence of severe bleeding tendency upon admission.
• • 12. Body temperature \<30℃ upon admission.
• • 13. Pregnant or lactating women, or reproductive-age females with elevated serum human Chorionic Gonadotropin (hCG) levels.
• • 14. Other conditions deemed unsuitable for this trial by the principal investigator.