NCT04280237撤回不适用
Pharmacological Study of Cefazolin Antibioprophylaxis in Liver Transplantation
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Cefazolin blood concentration
研究概览
简要总结
This study describes Cefazolin pharmacokinetics variation to target levels during liver transplantation.
详细描述
Cefazolin is one of the many drugs used in antibiotic prophylaxis during liver transplantation. However there are no study describing its pharmacokinetics during liver transplantation.
Due to the severe pharmacokinetics interactions caused by both prior hepatopathy and surgical techniques we suppose that Cefazolin blood levels are very different from those targeted for antibiotic prophylaxis.
This study aim to describe pharmacokinetics of Cefazolin during liver transplantation in order to adapt antibiotic prophylaxis strategy in case of unadapted measured levels.
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 over 18
- •patient undergoing liver transplantation
- •receiving Cefazolin as perioperative antibiotic prophylaxis to prevent surgical site infections
排除标准
- •pregnant women
- •legal protection or protected adults
- •ongoing antibiotic treatment before liver transplantation
- •patient inability to receive information or express opposition to the study.
- •patient refusing participation
结局指标
主要结局
Cefazolin blood concentration
时间窗: Baseline up to 10 hours
Cefazolin blood concentration will be measured at the moment of surgical incision and every hour until end of surgery
次要结局
- Assess correlations between Cefazolin blood concentration and Cirrhosis etiology(baseline)
- Assess correlations between Cefazolin blood concentration and Blood loss(End of surgery)
- Assess correlations between Cefazolin blood concentration and CHILD-PUGH score(baseline)
- Assess correlations between Cefazolin blood concentration and Hemodialysis(baseline)
- Assess correlations between Cefazolin blood concentration and MELD score(baseline)
- Assess correlations between Cefazolin blood concentration and Transplantation indication(baseline)
- Assess correlations between Cefazolin blood concentration and Ascitis(Baseline)
- Assess correlations between Cefazolin blood concentration and Urine output(End of surgery)
- Assess correlations between Cefazolin blood concentration and Red cell transfusion unit(End of surgery)
- Assess correlations between Cefazolin blood concentration and Plasma transfusion unit(End of surgery)
- Assess correlations between Cefazolin blood concentration and Colloid infusion(End of surgery)
- Assess correlations between Cefazolin blood concentration and Portal vein clamping time(End of surgery)
- Assess correlations between Cefazolin blood concentration and Intraoperative blood salvage(End of surgery)
- Assess correlations between Cefazolin blood concentration and Surgical site infection(Day 28)
- Assess correlations between Cefazolin blood concentration and Crystalloid infusion(End of surgery)
- Assess correlations between Cefazolin blood concentration and Transjugular intrahepatic portosystemic shunt (TIPS)(baseline)
- Assess correlations between Cefazolin blood concentration and Creatinine(baseline)
- Assess correlations between Cefazolin blood concentration and Surgery duration(End of surgery)
- Assess correlations between Cefazolin blood concentration and Basal cardiac index(Baseline)
- Assess correlations between Cefazolin blood concentration and Minimal cardiac index(End of surgery)
- Assess correlations between Cefazolin blood concentration and Albumin(baseline)
- Assess correlations between Cefazolin blood concentration and Platelet transfusion unit(End of surgery)
研究者
研究点 (1)
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