EUCTR2016-001788-34-DE进行中（未招募）1 期
Prospective, randomized study concerning personalized medicine with Pentaglobin® after interventional infectious source control in peritonitis patients - PEPPER
niversity Hospital Aachen, AöR, Dean of the Medical Faculty of the RWTH Aachen for the Managing Board of the University0 个研究点目标入组 200 人开始时间: 2017年6月1日最近更新:
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相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. the patient has a diagnosis of secondary or quaternary peritonitis.
- •2. the time of source control is within 6 h of the indication (defined as the date and time of registration for surgery or minimally invasive procedure).
- •3. sepsis and/or septic shock (according to the current sepsis guideline of the German Sepsis Society) are present.
- •4. the SOFA score is = 8.
- •5. the concentration of IL-6 is = 1000 pg/ml.
- •6. antibiotic therapy is started within 12 h after admission to the intensive care unit.
- •7. the informed consent form has been signed by the patient himself and/or his legal representative (such as his spouse, a proxy with effective power of attorney for health care or a court-appointed guardian) or by a consultant.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 200
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 200
排除标准
- •1. the patient has a life expectancy of less than 90 days due to medical conditions unrelated to peritonitis, sepsis and/or septic shock.
- •2. for female patients only: There is a pregnancy or the patient is breastfeeding.
- •3. the patient is a minor (<18 years).
- •4. The patient has known chronic renal dysfunction requiring dialysis (creatinine = 3.4 mg/dl or creatinine clearance = 30 mL /min /1.73 m2).
- •5. the patient has acute, primarily non-infectious pancreatitis or mediastinitis.
- •6. the BMI is > 40.
- •7. the patient has a contraindication to the study medication.
- •8. patient has participated in another drug study within the last 30 days.
- •9. the patient has a dependent or employment relationship with the sponsor or investigator.
- •10. the patient is institutionalised by court or regulatory order.
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