Cytokine Clearance With Cytoabsorbant Device During Cardiac Bypass: a Pilot Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change in Cytokine levels
研究概览
简要总结
Investigators are planning a single center pilot randomized controlled trial to assess the potential of a Cytoadsorbant filter (Cytosorb®, Germany) to remove cytokines from the blood during cardiac surgery.
Investigators will screen all patients undergoing cardiac surgery and approach those deemed at risk of post surgical complications [≥ 1 among: age >75 years old, double valvular replacement, complex surgery with expected CPB time >100 min, redo cardiac surgery, pre-op chronic renal failure (plasma creatinine level >120 mcmol/l) or chronic heart failure (LVEF <35%)].
Patients with end-stage renal disease (dialysis dependence), undergoing an emergency procedure or an off-pump procedure, those who decline informed consent as well as those enrolled in another conflicting study will be excluded.
Eligible patients will be approached, consented and enrolled in the trial. Patients will then be randomized to either receive conventional CPB (control arm) or CPB plus Cytosorb (intervention arm). The target population is 30 patients (15 per arm).
For this pilot study, investigators main outcome will be differences between the two arms in measurement of serum levels for IL-2, IL-6, IL-10 and TNF alpha at baseline (pre-operatively), on ICU admission, as well as 6 and 24 hrs post CPB.
Secondary outcomes will be changes in coagulation factors serum levels, the need for vasopressors, inotropes, mechanical ventilation and renal replacement therapy, ICU and hospital length of stay as well as in-hospital mortality.
Recruitment period should span from May 2016 to April 2017.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, 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
- •Patients planned for elective cardiac surgery requiring CPB and (≥1 among):
- •Age >75 years' old AND / OR
- •Double valvular replacement AND / OR
- •Complex surgery with expected CPB time >120 min AND / OR
- •Redo cardiac surgery AND / OR
- •Pre-op chronic renal failure (GFR<30 ml/min) AND / OR Chronic heart failure (LVEF <40%)
排除标准
- •End stage renal disease (dialysis dependence)
- •Emergency procedure
- •Active infectious endocarditis
- •Off-pump procedure planned
- •Non steroidal anti-inflammatory treatment in the previous 7 days
- •Corticosteroids administration in the previous 7 days
- •No informed consent
- •Enrolment in another conflicting study
研究组 & 干预措施
Control
Conventional cardio-pulmonary bypass
Cytosorb
Cytosorb added to cardio-pulmonary bypass
干预措施: Cytosorb (Device)
结局指标
主要结局
Change in Cytokine levels
时间窗: From Baseline (Preoeratively) to 6hrs post CPB
次要结局
- In-hospital mortality(90 days)
- ICU length of stay(90 days)
- Change in Cytokine levels(From Baseline (Preoeratively) to end of CPB)
- Change in Coagulation factors serum levels(From baseline (pre-operatively) to end of CPB as well as 6 hrs and 24 hrs post CPB)
- Duration of the need for vasopressors(28 days)
- Duration of mechanical ventilation(28 days)
- Hospital Length of stay(90 days)
研究者
Antoine Schneider
physician associate
Centre Hospitalier Universitaire Vaudois