CTIS2024-513526-27-00招募中1 期
Prospective, randomized study concerning personalized medicine with Pentaglobin® after interventional infectious source control in peritonitis patients - 15-167
niversitaetsklinikum Aachen AöR0 个研究点目标入组 200 人开始时间: 2024年5月2日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 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
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •the patient has a diagnosis of secondary or quaternary peritonitis., 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)., sepsis and/or septic shock (according to the current sepsis guideline of the German Sepsis Society) are present., the SOFA score is = 8., the concentration of IL-6 is = 1000 pg/ml., antibiotic therapy is started within 12 h after admission to the intensive care unit., 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.
排除标准
- •the patient has a life expectancy of less than 90 days due to medical conditions unrelated to peritonitis, sepsis and/or septic shock., the patient is institutionalised by court or regulatory order., for female patients only: There is a pregnancy or the patient is breastfeeding., the patient is a minor (<18 years)., The patient has known chronic renal dysfunction requiring dialysis (creatinine = 3.4 mg/dl or creatinine clearance = 30 mL /min /1.73 m²)., the patient has acute, primarily non-infectious pancreatitis or mediastinitis., the BMI is > 40., the patient has a contraindication to the study medication., patient has participated in another drug study within the last 30 days., the patient has a dependent or employment relationship with the sponsor or investigator.
研究者
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