2024-513526-27-00招募中2 期
Prospective, randomized study concerning personalized medicine with Pentaglobin® after interventional infectious source control in peritonitis patients
Universitaetsklinikum Aachen AöR14 个研究点 分布在 2 个国家目标入组 200 人开始时间: 2024年5月29日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 14
- 主要终点
- Change in multiple organ failure (MOF) score (determined in the organs lung, heart, kidney, liver, blood) from baseline to day 7 after source control, in the course of peritonitis.
研究概览
简要总结
Change in multiple organ failure (MOF) score (determined in the organs lung, heart, kidney, liver, blood) from baseline to day 7 after source control, in the course of peritonitis.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
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 ≥
- •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 >
- •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.
结局指标
主要结局
Change in multiple organ failure (MOF) score (determined in the organs lung, heart, kidney, liver, blood) from baseline to day 7 after source control, in the course of peritonitis.
Change in multiple organ failure (MOF) score (determined in the organs lung, heart, kidney, liver, blood) from baseline to day 7 after source control, in the course of peritonitis.
次要结局
- Death within 28 days
- Death within 90 days
- Change in MOF score from baseline to day 5
- Multi-organ failure (> 4 MOF points) on day 7
研究者
Univ.-Prof. Dr. med. Gernot Marx
Scientific
Universitaetsklinikum Aachen AöR
研究点 (14)
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