The Effects of High-cutoff (HCO) Hemofiltration in the Immediate Postoperative Period on Systemic Inflammatory Response Syndrome (SIRS) and Renal Recovery in Cardiac Surgery Patients With a High Risk for Renal Failure. (HICOSIRS)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- IL6/IL10 ratio
研究概览
简要总结
A high cut off dialyzer (septeX) is tested in patients after cardio-thoracic surgery with incidence of "systemic inflammatory response syndrome" (SIRS) and associated increased risk for acute kidney injury (AKI). Hypothesis: The high cut off dialyzer (septeX) can increase the postoperative IL-6/Il-10 ratio.
详细描述
Cardiac surgery associated systemic inflammatory response syndrome (SIRS) plays an important pathophysiological role in the development of AKI in patients after cardiothoracic surgery.
Previous studies have shown that the elimination of inflammatory mediators can be either achieved by Continuous Venous Venous Hemodialysis(CVVHD) or Continuous Venous Venous Hemofiltration (CVVH) by using a high-cutoff (HCO) membrane with a cut-off 45kD. Data from patients treated with HCO-CVVHD during septic shock show a reduction in systemic cytokines and improved hemodynamics.
No data about the effects of early HCO-CVVH in cardiac surgery patients with a high risk of Cardiac Surgery associated AKI and consequently a high rate of postoperative renal replacement therapy (RRT) are available.
It is of note that patients with Euroscore > 6 are on high risk to develop SIRS associated AKI.
No pharmacological anti-inflammatory approach has convincingly shown to prevent renal dysfunction in these patients.
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
- •Age ≥ 18 years
- •Scheduled for complex / prolonged cardiac surgery (i.e.combined CABG+ valve surgery, Redo surgery) with an anticipated CPB time > 120 min
- •CKD with an e GFR < 50ml/min/m2
- •Euroscore > 6
排除标准
- •End stage CKD (dialysis dependent) renal failure before surgery
- •Radiocontrast exposure within 24 hours before surgery
- •Active endocarditic with antibiotic treatment
- •pulmonary disease with chronic hypoxia
- •Clinically significant liver dysfunction (bilirubin > 1.8mg/dl (30µmol/L))
- •Known HIV, HCV infection
- •Alcoholism
- •Active uncontrolled infection
- •Pregnancy or lactation
- •Inability to give informed consent to participate in the study
结局指标
主要结局
IL6/IL10 ratio
时间窗: Change from Baseline in IL6/IL10 ratio at 48h post cardiac surgery and last day at hospital (expected average of 2 weeks after cardiac surgery)
To test, if immediate postoperative HCO-CVVH reduces systemic inflammation (determined as the ratio between Il-6 / Il-10) in patients with a high risk for CSA-AKI in comparison with a treatment without early RRT. To calibrate for differences in baseline cytokine levels and with respect to the high variability of cytokines in the postoperative period the area-under-the-curve (AUC) of the postoperative increase in the IL-6/Il-10 ratio until 48h will be used.
次要结局
- adverse effects(48h after cardiac surgery)
- determination of immediate postoperative HCO-CVVH improvement(6 month post cardiac surgery)
- Laboratory assessments(48h after cardiac surgery and last day at hospital (expected average 2 weeks))