Effect of Haemoadsorption During Cardiopulmonary Bypass on Patients After Heart Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Difference in maximal cytokine peak levels (IL-1β, IL-6, IL-33, TNF-α, IL-10)
研究概览
简要总结
To investigate whether the use of haemoadsorption (HA) on cardiopulmonary bypass during heart transplantation (HTX) has an effect on circulating cytokine levels for the first 120 hours after HTX and induces a decreased inflammatory response, increased anti-inflammatory response or immunosuppressive response. Additionally, the influence of HA on primary graft dysfunction, postoperative cerebral dysfunction, postoperative fluid accumulation, renal dysfunction, duration of mechanical ventilation, length of ICU-stay and 30-day mortality should be investigated
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
- •Adult patients undergoing heart transplantation
排除标准
- •Declined informed consent
- •Age < 18 years#
- •Receiving antileukocyte drugs
- •Receiving TNF-α Blockers, immunosuppressive drugs (e.g. tocilizumab)
- •Ex-vivo perfusion
研究组 & 干预措施
Adsorber Group
Surgery with CPB will be performed according to institutional standards, depending on indications and surgical preferences.
For the intervention group (adsorber-group), the CytoSorb adsorber will be installed on the CPB machine in a parallel circuit to the body circulation. The flow through the filter will be driven by a roller pump with 300-400 ml.min-1.
干预措施: CytoSorb Adsorber (Device)
Control
The control group (no-adsorber group) will be treated similarly, but no filter circuit will be installed.
结局指标
主要结局
Difference in maximal cytokine peak levels (IL-1β, IL-6, IL-33, TNF-α, IL-10)
时间窗: 5 days
Difference in maximal cytokine peak levels in various cytokine levels compared to baseline measured by ELISA
次要结局
- Mechanical Ventilation(up to 4 weeks)
- Difference of immunosuppression (TTV)(30days)
- 30-day mortality(30 days)
- Difference of immunosuppression (sST2)(30days)
- primary graft dysfunction score(7 days)
- Delirium(5 days)
研究者
Dr. Martin Bernardi
Principal Investigator
Medical University of Vienna