Neuroprotective Effect of Butylphthalide for Cardiac Arrest Patients

NCT ID: NCT06572085

Last Updated: 2025-04-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 350 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2027-12-31

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 to improve neurological function in resuscitated brain-injured patients has been a focus of research in the field of resuscitation. Butanephthalein has an ameliorating effect on the damage of central nervous function in patients with acute ischemic stroke, and can promote the improvement of patients' neurological deficits. On this basis, the present study was designed as a multicenter, prospective randomized controlled experiment, with internationally accepted methods for assessing near-term and long-term neurological function, to determine the effectiveness of butalbital in improving neurological function after cardiac arrest, with the aim of searching for new methods and ideas to improve neurological function and prognosis after cardiac arrest.

Conditions

Butylphthalide; Cardiac Arrest; Neuroprotective Drugs

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Butylphthalide

Butylphthalide and Sodium Chloride Injection 100ml ivgtt bid 14days

Group Type: EXPERIMENTAL

Butylphthalide and Sodium Chloride Injection

Intervention Type: DRUG

All enrolled patients will undergo standard treatment as per international guidelines, concurrently receiving either NBP or placebo therapy. Patients in the experimental group will receive intravenous infusion of 100ml NBP injection twice daily, while patients in the control group will receive intravenous infusion of 100ml saline solution twice daily. Each patient will receive continuous medication for 14 days.

Saline Solution

Saline Solution 100ml ivgtt bid 14days

Group Type: PLACEBO_COMPARATOR

Saline Solution

Intervention Type: DRUG

All enrolled patients will undergo standard treatment as per international guidelines, concurrently receiving either NBP or placebo therapy. Patients in the experimental group will receive intravenous infusion of 100ml NBP injection twice daily, while patients in the control group will receive intravenous infusion of 100ml saline solution twice daily. Each patient will receive continuous medication for 14 days.

Interventions

Butylphthalide and Sodium Chloride Injection

All enrolled patients will undergo standard treatment as per international guidelines, concurrently receiving either NBP or placebo therapy. Patients in the experimental group will receive intravenous infusion of 100ml NBP injection twice daily, while patients in the control group will receive intravenous infusion of 100ml saline solution twice daily. Each patient will receive continuous medication for 14 days.

Intervention Type: DRUG

Saline Solution

All enrolled patients will undergo standard treatment as per international guidelines, concurrently receiving either NBP or placebo therapy. Patients in the experimental group will receive intravenous infusion of 100ml NBP injection twice daily, while patients in the control group will receive intravenous infusion of 100ml saline solution twice daily. Each patient will receive continuous medication for 14 days.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tang Ziren

OTHER

Sponsor Role: lead

Responsible Party

Tang Ziren

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Beijing Chao-Yang Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Ziren Tang, Ph.D

Role: CONTACT

tangziren1970@163.com

+86 010-85231530

Facility Contacts

Hao Cui, M.D

Role: primary

cuihao1337@outlook.com

+86 15726621992

Other Identifiers

2023-11-30-4

Identifier Type: -

Identifier Source: org_study_id