Pancreatic Antibiotic Concentration Evaluation Assessment
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Antibiotic concentration ratio between pancreatic fluid and plasma
研究概览
简要总结
This observational study aims to evaluate the penetration of intravenously administered antibiotics into pancreatic fluid collections in patients with suspected infected walled-off pancreatic necrosis (WOPN). In selected patients undergoing percutaneous or endoscopic drainage of the collection as part of their clinical care, a small sample of pancreatic fluid will be collected and analyzed to determine the concentration of the administered antibiotic.
At the same time, a blood sample will be taken to assess the antibiotic concentration in plasma. By comparing the concentrations in pancreatic fluid and plasma, the study seeks to determine the extent to which different antibiotics (e.g., meropenem or piperacillin-tazobactam) reach the site of infection within the pancreas.
All procedures performed as part of the study, with the exception of the antibiotic concentration measurement, are standard components of routine care for patients with complicated acute pancreatitis. Participation in the study does not alter the diagnostic or therapeutic management of the patient. Patients provide written informed consent before enrollment.
The results of this study may help optimize antibiotic dosing in patients with infected pancreatic collections and contribute to more effective and individualized treatment strategies in the future.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Signed informed consent
- •Undergoing percutaneous or endoscopic drainage/puncture of a pancreatic fluid collection
排除标准
- •- Failure or refusal to sign informed consent
结局指标
主要结局
Antibiotic concentration ratio between pancreatic fluid and plasma
时间窗: Within 6 hours after antibiotic administration
Ratio of antibiotic concentration in pancreatic fluid (WOPN) to plasma concentration, determined from simultaneously collected samples after intravenous antibiotic administration
次要结局
- Measured concentrations of antibiotics in pancreatic fluid and plasma(Within 6 hours after antibiotic administration)
研究者
Martin Harazim
Dr.
Brno University Hospital
