NCT05027529已完成不适用
ECMOsorb Trial - Impact of a VA-ECMO in Combination With CytoSorb in Critically Ill Patients With Cardiogenic Shock- A Prospective, Randomized, Blinded, Monocenter Trial.
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Change in inotropic score after 72h (difference between the two study groups)
研究概览
简要总结
In the ECMOsorb study the impact of a veno-arterial -ECMO in combination with an extracorporeal cytokine hemadsorption system in critically ill patients with cardiogenic shock is to be examined
详细描述
The prospective, interventional, randomised controlled and blinded ECMOsorb study investigates in critically ill patinets with cardiogenic shock and with veno-arterial ECMO (VA-ECMO) treatment the impact of an extracorporeal cytokin hemadsorption system on hemodynamics, defined by the Inotropic Score 72 hours after initiation of the adsorber (intervention) or normal ECMO tube (control) in the VA-ECMO.
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)
盲法说明
masking by using a "black-box"; the control group only receives a regular ECMO tube
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
- •Cardiogenic shock of any cause and indication for VA-ECMO
- •Age between 18 and 80
- •Signed informed consent
排除标准
- •Current participation in another interventional trial
- •Pregnancy
- •Current immunosuppressive or immunomodulatory therapy
- •Contraindications to VA-ECMO implantation.
- •Patients with pre - existing sepsis (raised CPR, positive PCT, leukozytosis, fever, positive blood cultures).
- •Shock duration> 12 h before evaluation.
- •Severe PVD (peripheral vessel disease) making ECMO-implantation impossible.
- •Aortic valve insufficiency / stenosis at least II °.
- •Age > 80 years.
- •CNS disease with fixed, dilated pupils (not drug-induced).
- •Severe concomitant disease with limited life expectancy <6 months.
- •CPR> 60min.
- •Shock due to other reasons
- •HIT positive (Heparin induced thrombocytopenia)
- •Very low platelet counts (< 20,000/µl)
- •Body weight less than 45 kg
研究组 & 干预措施
VA-ECMO only
Placebo Comparator
standard ICU care WITHOUT CytoSorb
干预措施: VA-ECMO only (Other)
VA-ECMO and CytoSorb
Experimental
standard ICU care WITH CytoSorb
干预措施: CytoSorb (Device)
结局指标
主要结局
Change in inotropic score after 72h (difference between the two study groups)
时间窗: 72 hours
Inotropic Score: dopamine dose \[μg/kg/min\] + dobutamine dose \[μg/kg/min\] + 100x epinephrine dose \[μg/kg/min\] + 100x norepinephrine \[μg/kg/min\]
次要结局
- Interleukin 18(0 to 7 days after beginning of intervention)
- incidence of apoplexy(30 days after beginning of intervention)
- creatinine kinase(0 to 7 days after beginning of intervention)
- s-100(0 to 7 days after beginning of intervention)
- Measurement of right ventricular parameters(0 to 7 days after beginning of intervention)
- c-reactive protein(0 to 7 days after beginning of intervention)
- creatinine(0 to 7 days after beginning of intervention)
- EuroQuol 5D-3L Descriptive System(7 to 30 days after beginning of intervention)
- 30 day, ICU and in-hospital mortality(day 30 after beginning of intervention)
- Length of stay in ICU and total length of hospital stay until discharge/transfer(day 30 after beginning of intervention)
- Necessary Implantation of an Active Assist Device or heart transplantation(day 30 after beginning of intervention)
- SAPS II(0 to 7 days after beginning of intervention)
- APACHE II score(0 to 7 days after beginning of intervention)
- Modified Rankin scale(0 to 30 days after beginning of intervention)
- Measurement of kidney injury and kidney function(0 to 7 days after beginning of intervention)
- glomerular filtration rate (GFR)(0 to 7 days after beginning of intervention)
- urinary output(0 to 7 days after beginning of intervention)
- cystatin c(0 to 7 days after beginning of intervention)
- SOFA score(0 to 7 days after beginning of intervention)
- cerebreal performance category (CPC)(0 to 30 days after beginning of intervention)
- Glasgow coma scale (GCS)(0 to 30 days after beginning of intervention)
- EQ VAS(7 to 30 days after beginning of intervention)
- mean arterial pressure(0 to 7 days after beginning of intervention)
- mixed venous oxygen saturation(0 to 7 days after beginning of intervention)
- Interleukin 6(0 to 7 days after beginning of intervention)
- Procalcitonin(0 to 7 days after beginning of intervention)
- lactate(0 to 7 days after beginning of intervention)
- troponin(0 to 7 days after beginning of intervention)
- myoglobine(0 to 7 days after beginning of intervention)
- neuron specific enolase(0 to 7 days after beginning of intervention)
- galectin-3(0 to 7 days after beginning of intervention)
- Duration of: renal replacement therapy (CVVHD), mechanical ventilation, ECMO therapy, inotropic /vasopressor treatment(day 30 after beginning of intervention)
- heart failure re-hospitalisation(30 days after beginning of intervention)
- Measurement of left ventricular parameters(0 to 7 days after beginning of intervention)
- central venous oxygen saturation(0 to 7 days after beginning of intervention)
- arterial oxygen saturation(0 to 7 days after beginning of intervention)
- n-terminal pro brain natriuretic peptide (NT-proBNP)(0 to 7 days after beginning of intervention)
- Brain natriuretic peptide (BNP)(0 to 7 days after beginning of intervention)
研究者
Christian Schulze
Prof. Dr. med.
Jena University Hospital
研究点 (1)
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