Cytokine Adsorption During Complex Cardiac Surgery: the JACCS Controlled Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- SOFA score at 24 hours
研究概览
简要总结
This prospective single-centre randomized controlled trial aims at evaluating the safety and efficacy of hemoadsorption with HA-380® during cardio-pulmonary bypass in 40 patients undergoing complex cardiac surgery.
详细描述
Cardiopulmonary bypass (CPB) is an extracorporeal circuit used to divert blood from the heart and lungs and take over their functions during cardiac surgery. Cardiac surgery with CPB can induce a major inflammatory response, largely mediated by cytokines. In the most severe cases, this inflammation can lead to vasoplegia, hypotension and potentially end-organ damage.
The investigators hypothesised that the removal of inflammatory mediators (e.g. cytokines) from the blood during CPB could reduce the development of postoperative complications in patients with significant inflammation during cardiac surgery.
Patients undergoing complex cardiac surgery will be enrolled preoperatively and randomised 1:1 to receive either the investigational hemoadsorption treatment plus standard care (intervention group) or standard care alone (control group). Patients allocated to the intervention group will have an HA-380® cartridge (Jafron Biomedical, Guangdong, China) inserted into the CPB during circuit set-up. Hemoadsorption treatment will be performed throughout the duration of the CPB procedure.
For each patient, 4 blood samples will be taken for cytokine measurements (at the start of CPB, at the end of CPB, at ICU admission and 24 hours later). Data on vital signs, organs support, demographics and medical history will be collected in the electronic medical record.
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
- None
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
- •Adults (≥18 years old at study inclusion)
- •Planned for one of the following cardiac surgical procedures: heart transplantation after L-VAD (left ventricular assist device) implantation, OR surgical repair of a type A aortic dissection, OR urgent (within a few days) or emergent (within 24 hours) procedure for acute infectious endocarditis, OR cardiac surgery likely to require >180 min CPB time as estimated by the surgical team
- •Signed informed consent
排除标准
- •Indication to receive hemoadsorption during CPB for drugs removal
- •Women who are pregnant or breastfeeding
- •Previous enrolment into the current study
- •Off-pump procedure
- •Chronic immunosuppression
- •Known allergy to heparin or heparin induced thrombocytopenia
- •Severe thrombopenia (platelets count before surgery < 20g/L)
- •Patient who does not want to be informed of incidental findings
- •Participation in another study with investigational drug within the 30 days preceding and during the present study
- •Participation in another conflicting research study
研究组 & 干预措施
Control
Cardiopulmonary bypass will be conducted as per institutional protocols, without hemoadsorption (standard-of-care)
Hemoadsorption
Cardiopulmonary bypass (CPB) will be conducted as per institutional protocols and an HA-380® cartridge (Jafron Biomedical, Guangdong, China) will be inserted within the circuit for hemoadsorption.
干预措施: Hemoadsoprtion (Device)
结局指标
主要结局
SOFA score at 24 hours
时间窗: Within 24 hours of ICU admission
Difference between groups in the SOFA score measured within 24 hours after ICU admission
次要结局
- ICU and hospital length of stay(At time of hospital discharge, an average 20 days after ICU admission)
- ICU, hospital, and 28 days (from ICU admission) mortality(At time of hospital discharge, an average 20 days after ICU admission and up to 28 days after ICU admission)
- Days alive without respiratory support(At day 28 from ICU admission)
- Days alive without renal replacement therapy(At day 28 from ICU admission)
- Days alive without vasopressors(At day 28 from ICU admission)
- SOFA score at 48 hours(Measured between 24 hours and 48 hours after ICU admission)
- Post-operative complications(At time of ICU discharge, up to 7 days after ICU admission)
- Cytokines levels(at the end of CPB, at the admission in ICU and 24 hours after ICU admission)
研究者
Antoine Schneider
Principal Investigator
Centre Hospitalier Universitaire Vaudois