Hemoadsorption With CytoSorb® in Post-Cardiac Arrest Syndrome: a Pilot Study (The CATCH Trial: Post Cardiac Arrest Therapy With Cytosorb Hemoadsorption)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Incidence of Treatment-Emergent Adverse Events
研究概览
简要总结
This prospective single-centre randomized control trial aims at evaluating the safety and efficacy of hemoadsorption with CytoSorb® in 40 patients with Post-Cardiac Arrest Syndrome admitted to the ICU.
详细描述
Patients presenting Post-Cardiac Arrest Syndrome (PCAS) in the 24 hours following their admission in Intensive Care Unit will be randomly assigned either to a control group (standard of care) either to a "Hemoadsorption" group. In the latter, the patient will be connected in the 6 hours following randomization to an extracorporeal circuit, in which a Cytosorb ® cartridge will be placed. The circuit will be set up in hemoperfusion mode. The therapy will take place for a minimum of 12 hours and a maximum of 24 hours. Anticoagulation will be achieved using a regional heparin-protamin regimen.
Blood samples will be collected at randomization, T1 (6 hours post-randomization), T2 (12 hours after randomization), T3 (24 hours after randomization), T4 (48 hours after randomization) and T5 (48 hours after randomization), to assess change in inflammatory cytokine levels.
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 (Outcomes Assessor)
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
- •Adult (≥18 years old) patients admitted to the ICU after CA, at risk of PACS as defined by the presence of at least one of the following characteristics (at any time within 24hrs of CA):
- •Need for a vasoconstrictor (norepinephrine dose > 0.2 µg/kg/min to maintain MAP > 60-70 mmHg, , or equivalent vasoconstrictor agent) for at least one hour
- •Serum lactate level > 6 mmol/l
- •Time to ROSC > 25 minutes
排除标准
- •Evidence for patient's refusal to participate in clinical trials
- •Non commitment for ongoing medical therapy (imminent withdrawal of care)
- •Cardiac arrest caused by hemorrhagic shock
- •Contraindications to therapeutic heparinization
- •Shock of primary cardiac origin (LVEF <20%)
- •Platelet count <20 G/L
- •Deep immunosuppression state, as defined by neutrophils <1 G/L or CD4 <200 /mm3
- •Pregnancy
- •Acute sickle cell crisis
- •Refractory cardiac arrest with ECMO implantation
- •Need for renal replacement therapy at time of randomization
- •Concomitant enrolment in another study
- •Non availability of the research team at time of eligibility at time of randomization
研究组 & 干预措施
Hemoadsorption
Hemoadsorption is performed using a CytoSorb® cartridge.
干预措施: CytoSorb® Hemoadsorption (Device)
Control
Post-cardiac arrest management will be conducted as per institutional protocols.
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events
时间窗: From beginning of hemoadsorption to 24 hours after the end of hemoadsorption, incidence of adverse events such as haemorrhagic complications, catheter-insertion related complications and anaphylactoid reactions
Rate of intervention-related complications
Change in cytokine levels
时间窗: From baseline (randomization) to 72 hours after randomization
Plasma levels reduction of the following inflammatory mediators: IL-1β,IL-1Ra, IL-6, IL-8, IL-10 and TNF-α.
次要结局
- CRP and Procalcitonin Levels(Day 1, 2, 3 after randomization)
- In-hospital mortality(Day 14, 28 and 90 after randomization)
- Vasopressor requirements(From baseline (randomization) to 72 hours after randomization)
- Shock reversal(Within 24 hours from randomization)
- Sequential Organ Failure Assessment Score (SOFA)(Day 1 to 7 after randomization)
研究者
Antoine Schneider
Doctor
Centre Hospitalier Universitaire Vaudois