Neuroprotective Effect of Butylphthalide Injection on Patients With Return of Spontaneous Circulation After Cardiac Arrest：a Multicenter, Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 350
- 试验地点
- 1
- 主要终点
- The proportion of patients with a Cerebral Performance Category (CPC) Score of 1-2
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-80 years old.
- •Glasgow Coma Scale (GCS) scores ≤8 upon admission.
- •Return of Spontaneous Circulation (ROSC) ≥30min.
- •Signed the informed consent form.
排除标准
- •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.
研究组 & 干预措施
Butylphthalide
Butylphthalide and Sodium Chloride Injection 100ml ivgtt bid 14days
干预措施: Butylphthalide and Sodium Chloride Injection (Drug)
Saline Solution
Saline Solution 100ml ivgtt bid 14days
干预措施: Saline Solution (Drug)
结局指标
主要结局
The proportion of patients with a Cerebral Performance Category (CPC) Score of 1-2
时间窗: 6 months
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.
次要结局
未报告次要终点
研究者
Tang Ziren
Professor
Capital Medical University