Perioperative Cefuroxime in Obese Patients: Dosage According to the BMI
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Serum level of Cefuroxime
研究概览
简要总结
This study evaluates the dosage of perioperative cefuroxime for obese patients. Dosage was increased if the BMI was over 30kg/m*m and as well over 50kg/m*m. Drug levels were measured in blood and tissue.
详细描述
Cefuroxime is an often used antibiotic for surgery antibiotic prophylaxis to avoid surgical wound infection. In this study the dosage of cefuroxime was adjusted to the BMI:
less than 30kg/m*m: 1,5g 31-50kg/m*m: 3,0g more than 50kg/m*m: 4,5g
Cefuroxime was applicated 30 to 60 minutes before the begin of surgery. Drug Levels in blood and fat tissue were measured at skin cut (30-60 minutes after application of Cefuroxime), 45 minutes after skin cut (75-105 minutes after minutes after application of Cefuroxime) and at the end of surgery (up to 150 minutes after application of Cefuroxime) .
The hypothesis of this study is that adequate drug levels are reached in all groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •elective laparoscopic Intervention
- •BMI < 90 kg/m*m
- •age: 18-85 years
排除标准
- •known history of allergy to cefuroxime or other cephalosporines
- •absent consent skill
- •elective open surgery
- •preoperative therapy with antibiotics
- •patient's denial of the study
研究组 & 干预措施
Cefuroxime 1,5g
BMI <30kg/m*m
干预措施: Cefuroxime 1,5g (Drug)
Cefuroxime 3g
BMI 30-50kg/m*m
干预措施: Cefuroxime 3g (Drug)
Cefuroxime 4,5g
BMI >50kg/m*m
干预措施: Cefuroxime 4,5g (Drug)
结局指标
主要结局
Serum level of Cefuroxime
时间窗: up to 150 minutes after application of cefuroxime
Drug Serum Level at the end of surgery
Tissue level of Cefuroxime
时间窗: up to 150 minutes after application of cefuroxime
Drug Tissue Level at the end of surgery
次要结局
- Hospital Retention period(Time until hospital discharge, estimated time period: 5-7 days)
- Surgical site infections(Time until hospital discharge, estimated time period: up to two weeks)
研究者
Dr. med. Jakob Mueller
Senior Physician
Universitätsklinikum Hamburg-Eppendorf