Neuroprotective Effect of Butylphthalide for Cardiac Arrest Patients

NCT06572085 | Recruiting Phase 4

• 1 other identifier: 2023-11-30-4
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

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

  The primary outcome is the proportion of patients with a Cerebral Performance Category (CPC) score of 1-2 at 6months after randomization in each group.

  6 months

Study Arms (2)

Butylphthalide

EXPERIMENTAL

Butylphthalide and Sodium Chloride Injection 100ml ivgtt bid 14days

Drug: Butylphthalide and Sodium Chloride Injection

Saline Solution

PLACEBO COMPARATOR

Saline Solution 100ml ivgtt bid 14days

Drug: Saline Solution

Interventions

Butylphthalide and Sodium Chloride Injection 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.

Butylphthalide

Saline Solution 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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-80 years old.
• Glasgow Coma Scale (GCS) scores ≤8 upon admission.
• Return of Spontaneous Circulation (ROSC) ≥30min.
• Signed the informed consent form.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tang Ziren: lead

Study Sites (1)

Beijing Chao-Yang Hospital

Beijing, Beijing Municipality, 100020, China

RECRUITING

MeSH Terms

Conditions

Heart Arrest

Interventions

3-n-butylphthalide; Sodium Chloride; Saline Solution

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

Ziren Tang, Ph.D

CONTACT

+86 010-85231530; tangziren1970@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 25, 2024
• First Posted: August 26, 2024
• Study Start: January 1, 2022
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 11, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Starting 6 months after publication
• Access Criteria: The de-identified survey data will be made available for research purposes by contacting the corresponding authors

Locations

CN (1)