Neuroprotective Effect of Butylphthalide for Cardiac Arrest Patients

Phase 4

Recruiting

• Conditions: Butylphthalide; Cardiac Arrest; Neuroprotective Drugs

• Registration Number: NCT06572085
• Lead Sponsor: Tang Ziren

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-8-25
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 350

Inclusion Criteria

Inclusion Criteria:<br><br> 1. Age 18-80 years old.<br><br> 2. Glasgow Coma Scale (GCS) scores =8 upon admission.<br><br> 3. Return of Spontaneous Circulation (ROSC) =30min.<br><br> 4. Signed the informed consent form.<br><br>Exclusion Criteria:<br><br> 1. Cardiac arrest due to irreversible causes such as trauma, poisoning, etc.<br><br> 2. Cardiac arrest due to end-stage conditions such as advanced cancer.<br><br> 3. Persistent cardiogenic shock that is unreversed (defined as a systolic blood<br> pressure persistently <90mmHg despite treatment with fluid resuscitation,<br> vasopressor agents, and inotropic medications).<br><br> 4. Presence of pre-existing cerebrovascular disease prior to cardiac arrest or<br> confirmed intracranial hemorrhage by CT scan following admission.<br><br> 5. Pre-existing CPC scores of 3-5 prior to cardiac arrest.<br><br> 6. Prior use of NBP or any medication containing NBP before cardiac arrest.<br><br> 7. Presence of severe hepatic or renal dysfunction before cardiac arrest (defined as<br> =3× upper limit of normal alanine transaminase or =2× upper limit of normal<br> creatinine).<br><br> 8. Bradycardia or sick sinus syndrome occurs after ROSC.<br><br> 9. History of prior drug or food allergies, or known allergies to the medication<br> components used in this study.<br><br> 10. Existence of treatment limitations (patient or their legal representative refusing<br> advanced life support treatment, including mechanical ventilation, chest<br> compressions, targeted temperature management, etc.).<br><br> 11. Presence of severe bleeding tendency upon admission.<br><br> 12. Body temperature <30? upon admission.<br><br> 13. Pregnant or lactating women, or reproductive-age females with elevated serum human<br> Chorionic Gonadotropin (hCG) levels.<br><br> 14. Other conditions deemed unsuitable for this trial by the principal investigator.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The proportion of patients with a Cerebral Performance Category (CPC) Score of 1-2