CYtosorb Modulation of surgiCal infLammatiON During LVAD insErtion
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Increase in plasma IL-6 concentration
研究概览
简要总结
Mechanical circulatory support, specifically implantable continuous flow left ventricular assist device (CF-LVAD) therapy has been established as a viable treatment for rapidly deteriorating patients suffering from end stage heart failure either as bridge or alternative to heart transplantation. However, a large proportion of these patients experience severe complications in the early postoperative period including right ventricular failure or multi organ failure leading to increased mortality. The leading theory explaining these complications involves exaggerated systemic inflammatory response prior to, during and early after CF-LVAD insertion. Among the cytokines IL-6 appears to play a major role. There is increasing demonstration of the efficacy of a cytokine haemoadsorption (HA) technology in attenuating cytokine response and particularly IL-6 in various inflammatory states and emerging data on the safety of the Cytosorb® device in routine and complex cardiac surgery.
The study team hypothesizes that Cytosorb® treatment is feasible and safe in heart failure patients undergoing LVAD insertion and that it is effective in attenuating IL-6 secretion with benefit in the wider inflammatory and metabolic response to this high-risk surgery.
详细描述
The principle objectives of this study are:
- To investigate the efficacy of Cytosorb® treatment in attenuating perioperative changes in IL-6 during CF-LVAD implantation
- To investigate the feasibility, and safety of Cytosorb® treatment during CF-LVAD implantation.
- To pilot the effect of Cytosorb® treatment on vasoplegia and organ dysfunction with specific focus on right ventricle failure, liver failure and acute kidney injury (AKI).
- To establish a collaborative biobank of patient's biological samples to allow extensive characterisation of patient phenotype prior to CF-LVAD implantation and their individual inflammatory and metabolic responses to surgery and perioperative management.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (≥18 years), but ≤70 years; Scheduled for elective LVAD implantation with the use of cardiopulmonary bypass; Written informed consent for participation
排除标准
- •Poor spoken and/or written language comprehension
- •Declined or missing informed consent
- •LVAD implant planned without use of CPB
- •Total Artificial Heart implantation
- •Planned CPB temperature < 32 °C
- •AIDS with a CD4 count of < 200/μL
- •Severe thrombocytopenia (PLT <50000
- •Application of contrast medium on the day of surgery
- •Immunosuppressive therapy or long-term therapy with corticosteroids
- •Contraindication to anticoagulation with heparin
- •Participation in another clinical intervention trial
结局指标
主要结局
Increase in plasma IL-6 concentration
时间窗: from baseline to the time of arrival to intensive care unit (approximately 4 hours).
次要结局
- 28 day mortality(28 days after surgery)
- Time of mechanical ventilation(From Baseline through ICU discharge (approximately 7 days))
- Changes in IL-6 concentrations at various time points after surgery until ICU discharge(from baseline, 6, 12, 24, 48 and 72 hours after surgery and at ICU discharge, approximately 7 days)
- Length of ICU stay(From Baseline through ICU discharge (approximately 7 days))
- Incidence of serious device related adverse events from the time of enrolment through ICU discharge(from the time of enrolment through ICU discharge (approximately 7 days))
- Feasibility based on number of patients eligible and receiving study intervention(From Baseline through ICU discharge (approximately 7 days))
- Incidence and progression of vasoplegia(from baseline to 24 hours after surgery)
- Prevalence of right ventricle dysfunction(From baseline to 72 hours after surgery)
- Incidence and progression of Acute Kidney Injury (KDIGO criteria)(From Baseline through ICU discharge (approximately 7 days))
- Sequential Organ Failure Assessment Score (SOFA)(From Baseline through ICU discharge (approximately 7 days))
- Prevalence of liver dysfunction(from baseline to 72 hours after surgery)