The OXIRIS Filter in Septic Shock : the Adsorption of Endotoxin and Cytokines Improves the Haemodynamic , the Renal Function , and the Metabolic Response
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Hemodynamic Data
研究概览
简要总结
Patients with Sepsis / Septic Shock and AKI are submitted to Continuous Renal Replacement Therapy with the oXiris filter . The pro- inflammatory mediators , the endotoxin , interleukin 10 , the main cardiorespiratory indices and renal parameters are evaluated at the entry of the study and at the end of the treatment.
详细描述
Patients with a diagnosis of sepsis or septic shock Gram + , Gram - and acute renal failure All patients are submitted to Continuous Renal Replacement Therapy with the treated heparin-coated membrane (oXiris;Baxter );
- Citrate Anticoagulation or Heparin with thromboelasthograpy monitoring .
- Hemodynamic monitoring with dynamic parameters ( Cardiac Index ,Stroke Volume Variation , Pulse Pressure Variation ) and Echocardiography
- Indirect Calorimetry ( before Continuous Renal Replacement Therapy and after 1 hour stopping Continuous Renal Replacement Therapy )
- Laboratory: white blood cell, creatinine, procalcitonin, Interleukin -6, Interleukin -10, Endotoxin , Lactate, diuresis, tromboelastography (post filter and arterial sample ) and dosage of Plasminogen Activator Inhibitor -1 at the same sites.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age <18 years 75 years >
- •Diagnosis of sepsis or septic shock (Sepsis III)
- •Mechanical Ventilation or non Invasive ventilation with PaO2 /FIO2 <
- •Renal failure ( AKI ≥ 1)
- •Endotoxin ( EAA ) : EAA ≥ 0.6 -0.9 > or IL6 > 150 pg/mL
排除标准
- •Pregnancy;
- •Age < 18 years 75>
- •Chronic Renal failure or previous CRRT
- •Immunological disease or immunosuppressive drugs or EAA < 0.6 with IL 6 in the normal range.
- •CGS < 8 due to hemorrhagic or ischemic event.
- •ECMO v-v or a-v or ECCO2 removal.
- •No resolution of the surgical source of infection
- •Terminal condition
- •Any contraindication to heparin and other anticoagulant.
- •Other pathological conditions in which the oXiris filter is not indicated and other therapeutic options are required. (eg . Hepatic failure , Cardiac failure )
结局指标
主要结局
Hemodynamic Data
时间窗: At the 24 - 48 hours after starting of the treatment
Changes of vasoactive drugs concentration (micr/Kg/min)
Respiratory Data
时间窗: At the 24 - 48 hours after starting of the treatment
Changes of P/F ratio
Renal Data
时间窗: At the 24 - 48 hours after starting of the treatment
Changes of Urinary Out Put ( mL/ 24 hours)
Calorimetric data
时间窗: At the 24 - 48 hours after starting of the treatment
Changes of VO2 (mL / min)
次要结局
- Inflammatory data(At the 24 - 48 hours after starting of the treatment)
- Coagulation data(At the 24 - 48 hours after starting of the treatment)
- Cytokines Data(At the 24 - 48 hours after starting of the treatment)
- Cytokines data(At the 24 - 48 hours after starting of the treatment)
研究者
FRANCO TURANI
Adjunt Professor of Anesthesia and Intensive Care
University of Rome Tor Vergata