Serum and Peritoneal Concentration in Antibiotics During the Surgical Management of Peritonitis: SPAC
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Serum and peritoneal beta lactams concentrations at 3 times
研究概览
简要总结
SPAC is a pilote monocentric prospective study about peritonitis and antibiotics pharmacokinetic and pharmacodynamic. The investigators will included 50 patients during 2 years in the University Hospital of Nancy.
The aim of this study is to determine if the beta-lactam dosages recommended by the guidelines for management of intra-abdominal infections (published by the Société française d'anesthésie et de réanimation (Sfar) in december 2015) permitted the achievement of adequatly serum and peritoneal concentrations in the medical and surgical management of peritonitis.
The investigators will collected 3 pairs of serum and peritoneal fluid samples at 3 different times: peritoneal incision, arrival in ICU and 24 hours after admission in ICU in order to compare the concentrations and the minimal inhibitor concentration of bacteria.
The hypothesis is that of a serum and peritoneal antibiotic under dosage.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •Minimun age limits 18 years
- •Patients with peritonitis (community or nosocomial) regardless of pathology involved
- •Patients treated in the Universty Hospital of Vandoeuvre les Nancy (abdominal surgery unit and surgical Intensive care unit JM Picard)
排除标准
- •Beta lactam allergy
- •Pregnancy
- •Age less than 18 years
- •No respect of recommandations for antibiotics ( molecule and dosage)
- •Person under legal protection
结局指标
主要结局
Serum and peritoneal beta lactams concentrations at 3 times
时间窗: 3 times : Peritoneal incision, Admission in ICU and 24 hours after admission in ICU
Population : patients with surgical peritonitis. The concentrations are compared with the minimum inhibitory concentrations of bacteria to diagnose a sub therapeutic dosage.
次要结局
- Morbidity of included patients(Reception on the 8th postoperative day)
- Evaluate the relationship between serum and peritoneal concentrations of beta-lactam(Statistical analysis after 2 years of inclusion)
- Mortality of included patients(Reception on the 8th postoperative day)
- Factors associated with an antibiotic under-dosage(Statistical analysis after 2 years of inclusion)