A Randomized Controlled Clinical Study of Early Application of Levosimendan to Improve Cardiac Dysfunction and Neurological Prognosis in Patients With Cardiac Arrest
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- Cerebral Performance Category (CPC)
研究概览
简要总结
This study is intended to use a multicenter, double-blind, superior effect, placebo controlled randomized controlled clinical trial to explore the therapeutic effect of Levosimendan (within 6 hours after the recovery of spontaneous circulation) on mortality and multiple organ dysfunction such as heart and brain in patients with cardiac arrest who have recovered from active Cardiopulmonary resuscitation but have low cardiac output syndrome and coma, and the impact of 30-day mortality and neurological function 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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1: Age>18 years old
- •2: After active Cardiopulmonary resuscitation, patients with cardiac arrest obtain the recovery of spontaneous circulation (ROSC), which is defined as having palpable arterial pulse lasting for more than 20 minutes
- •3: Patients with witnessed cardiac arrest
- •4: ROSC lasts for less than 60 minutes
- •5: Low cardiac output syndrome after ROSC (LVEF<40%)
- •6: Still in a coma after ROSC, Glasgow score<8 points
- •7: Complete enrollment within 180 minutes after ROSC
排除标准
- •1: Patients receiving extracorporeal Cardiopulmonary resuscitation
- •2: Patients with severe neurological deficits prior to cardiac arrest
- •3: Patients with severe renal dysfunction (creatinine clearance rate<30ml/min)
- •4: Patients with confirmed or suspected pregnancy
- •5: Patients with Intracranial hemorrhage
- •6: Patients with end-stage diseases, such as advanced malignant tumors or other severe wasting diseases
- •7: Patients who are unwilling to participate in the study
研究组 & 干预措施
Levosimendan group
The administration scheme of Levosimendan is continuous intravenous infusion at the rate of 0.05-0.2 μg/kg/min for 24 hours, and no load is given to reduce the risk of Hypotension.
干预措施: Levosimendan Injection (Drug)
Placebo group
The placebo group received continuous intravenous infusion of physiological saline at the rate of 0.05-0.2 μg/kg/min for 24 hours, while also receiving comprehensive cluster therapy with PCAS.
干预措施: physiological saline (Drug)
结局指标
主要结局
Cerebral Performance Category (CPC)
时间窗: On the 30th day after cardiac arrest
The mortality rate and neurological prognosis at 30 days after cardiac arrest. The evaluation of neurological function adopts CPC score, with CPC 1-2 grading indicating a good prognosis for neurological function and CPC 3-5 grading indicating a poor prognosis for neurological function.
次要结局
- Survival rate(after 1 week of resuscitation)
- Echocardiography(On the first week after resuscitation)
- Neuron-Specific Enolase (NSE)(On the first week after resuscitation)
- Gray-to-White Matter Ratio (GWR)(On the first week after resuscitation)
- Serum creatinine(On the first week after resuscitation)
研究者
Du Lanfang
associate professor
Peking University Third Hospital