Status:
RECRUITING
Neuroprotective Effect of Butylphthalide for Cardiac Arrest Patients
Lead Sponsor:
Tang Ziren
Conditions:
Butylphthalide
Cardiac Arrest
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
Cardiac arrest is one of the critical illnesses that is directly life-threatening, and patients who survive cardiac arrest develop severe neurological deficits or even die. The effectiveness of drugs ...
Eligibility Criteria
Inclusion
- Age 18-80 years old.
- Glasgow Coma Scale (GCS) scores ≤8 upon admission.
- Return of Spontaneous Circulation (ROSC) ≥30min.
- Signed the informed consent form.
Exclusion
- Cardiac arrest due to irreversible causes such as trauma, poisoning, etc.
- Cardiac arrest due to end-stage conditions such as advanced cancer.
- Persistent cardiogenic shock that is unreversed (defined as a systolic blood pressure persistently \<90mmHg despite treatment with fluid resuscitation, vasopressor agents, and inotropic medications).
- Presence of pre-existing cerebrovascular disease prior to cardiac arrest or confirmed intracranial hemorrhage by CT scan following admission.
- Pre-existing CPC scores of 3-5 prior to cardiac arrest.
- Prior use of NBP or any medication containing NBP before cardiac arrest.
- 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).
- Bradycardia or sick sinus syndrome occurs after ROSC.
- History of prior drug or food allergies, or known allergies to the medication components used in this study.
- Existence of treatment limitations (patient or their legal representative refusing advanced life support treatment, including mechanical ventilation, chest compressions, targeted temperature management, etc.).
- Presence of severe bleeding tendency upon admission.
- Body temperature \<30℃ upon admission.
- Pregnant or lactating women, or reproductive-age females with elevated serum human Chorionic Gonadotropin (hCG) levels.
- Other conditions deemed unsuitable for this trial by the principal investigator.
Key Trial Info
Start Date :
January 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
350 Patients enrolled
Trial Details
Trial ID
NCT06572085
Start Date
January 1 2022
End Date
December 31 2027
Last Update
April 11 2025
Active Locations (1)
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1
Beijing Chao-Yang Hospital
Beijing, Beijing Municipality, China, 100020