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临床试验/NL-OMON55605
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

研究者

发起方
Medisch Universitair Ziekenhuis Maastricht

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