TNF-a Antagonists Attenuate the Systemic Inflammatory Response in Post-cardiac Arrest Syndrome: a Multi Centre, Double-blind, Randomised Controlled Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 208
- 试验地点
- 1
- 主要终点
- 30-day survival rate
研究概览
简要总结
The investigators assessed the effect of TNF-α antagonism within 6 hours of return of spontaneous circulation on 30-day mortality in patients who remained comatose after cardiopulmonary resuscitation (CPR) following cardiac arrest . In addition, the investigators explored the role of this treatment in modulating the systemic inflammatory response and its potential impact on 90- and 180-day morbidity and mortality and neurological outcomes.
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
- Double (Participant, Care Provider)
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
- •Patients aged ≥18 years;
- •Patients with suspected cardiogenic cardiac arrest;
- •Patients with comatose state after ROSC (Glasgow Coma Scale [GCS] score <9);
- •Patients with Return of spontaneous circulation (ROSC) sustained for >20 minutes;
排除标准
- •Cardiac arrest due to trauma;
- •Suspected or confirmed hemorrhagic or ischemic stroke;
- •Cardiac arrest without witnessed collapse;
- •Admission body temperature <30°C;
- •Persistent cardiogenic shock (defined as systolic blood pressure below 90mmHg during the screening period despite adequate fluid resuscitation, vasopressors, and positive inotropic drug support);
- •Time from ROSC to randomization exceeding 4 hours;
- •Left ventricular ejection fraction (LVEF) <35% after ROSC;
- •Known allergy to TNF - α antagonist components
- •Known tuberculosis or other active infection;
- •Diagnosed advanced malignant tumors with an estimated survival period of less than 6 months;
- •Pre-existing severe neurological dysfunction before cardiac arrest (e.g., Cerebral Performance Category [CPC] 3-4);
- •End stage renal disease relies on dialysis;
- •Severe chronic obstructive pulmonary disease (COPD) and other diseases require long-term home oxygen therapy;
- •Being in a state of severe immune suppression (such as long-term use of immunosuppressants after autoimmune diseases or organ transplantation, or patients with severe immunodeficiency diseases)；
- •History of liver cirrhosis;
- •History of chronic heart failure, heart function III-IV (NYHA)
研究组 & 干预措施
intervention group
Patients in the intervention group received a TNF-α antagonist (infliximab) within 6 hours after return of spontaneous circulation(ROSC).
干预措施: Infliximab (Drug)
control group
The control group patients received 0.9% sodium chloride injection within 6 hours after restoration of spontaneous circulation (ROSC).
干预措施: Sodium chloride injection USP, 0.9% (placebo) (Drug)
结局指标
主要结局
30-day survival rate
时间窗: 30 days after randomization.
All-cause survival rate of patients on day 30 after randomization.
次要结局
- systematic scoring(24 hours (h), 48 hours, 72 hours and 1 week after randomization)
- Rate of good neurological function assessed by Modified Rankin scale neurologic function scores and cerebral performance category scores(30 days, 3 months, and 6 months after randomization)
- prolong follow-up survival rate(3 months and 6 months after randomization)