NL-OMON55605已完成不适用
Cytokine adsorption for vasoplegic syndrome after cardiothoracic surgery - CYTATIO
Medisch Universitair Ziekenhuis Maastricht0 个研究点目标入组 40 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99(—)
入选标准
- •1. >= 18 year
- •2. Post elective cardiac surgery
- •3. Vasoplegic syndrome occurring within 12 hours after surgery, defined as:
- •a. High vasopressor dose (norepinephrin > 0.25 mcg/kg/min) needed for adequate
- •MAP (> 65 mmHg) despite adequate crystalloid fluid resuscitation (> 30 ml/kg
- •IBW), persisting more than one hour.
- •b. Echocardiographic evidence of adequate cardiac output, defined as cardiac
- •index > 2,5L/min/m2. Stroke volume is calculated as the product of Aortic
- •velocity time integral and left ventricular outflow tract diameter. Cardiac
- •output is calculated by multiplying stroke volume with heart rate. This is then
- •divided by body surface area to obtain cardiac index. , c. IF; a pulmonary
- •artery catheter was already inserted perioperatively:
- •- Cardiac index > 2,5l/min/m2 AND low systemic vascular resistance (SVRI < 1600
- •dynes/sec/cm5/m2 , SVR < 800 dynes/sec/cm5)
- •- OR; normalized vascular resistance at due to high-dose vasopressor use
- •(norepinephrin > 0.25 mcg/kg/min).
排除标准
- •- Severe coagulopathy resulting in hemodynamic instability
- •- Significant bleeding defined as 400 ml/1st hour, 200 ml/ 2nd hour, 100 ml/h;
- •necessitating rethoractomy or transfusion
- •- Severe thrombocytopenia (< 80)
- •- Cardiac tamponade
- •- Active infectious disease (non-profylactic antibiotics)
- •- Active inflammatory disorders or chronic use of immunosuppressive medication
- •- Need for extracorporeal life support system
- •- Severe renal dysfunction pre-operation (GFR <30) or prior kidney transplant
- •- Contra-indications for PiCCO: Atrial or ventricular arrhythmia at time of
- •inclusion, Intra-Aortic Balloon pump, Aortic aneurysm, Pneumonectomy, Pulmonary
- •embolism, Intracardiac shunt
- •- Allergy for: polystyrene/divinylbenzene, polycarbonate, polypropylene,
- •silicone and polyester
- •- Acute liver failure with blood transaminases values >1000 IU/L
- •- Pregnancy
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