Comparison Between Post - Surgical Intraperitoneal Antibiotics Administration Vs. Intravenous Pre- Surgical Administration for the Prevention of Peritonitis After Insertion of Peritoneal Dialysis Catheter in Peritoneal Dialysis Patients
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Peritonitis
研究概览
简要总结
An intraperitoneal implanted catheter is always necessary to perform Peritoneal Dialysis. Catheter insertion has been associated with infectious complication such as Exit Site Infection (ESI), Tunnel Infection and Peritonitis. The last one may lead to loss of the technique because the need of catheter removal. Most of international guidelines recommends the use of prophylactic antibiotics. Different protocols has been used, mostly intravenous single injection before the procedure. For the last 25 years our unit gives a single intraperitoneal dose of Cefazolin immediately after the catheter insertion. The aim of this study is compare the effect of a pre- operative IV dose os Cefazolin with a post- procedure intraperitoneal single dose administration of the same drug.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 100 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects suffering from Chronic Kidney Disease, candidates to a intra- peritoneal catheter insertion
排除标准
- •Pregnancy; Active antibiotic treatment before the procedure; Known allergy to Cefazolin
研究组 & 干预措施
Intraperitoneal
One single dose of intraperitoneal Cefazolin 1000 mg via the recently inserted peritoneal catheter
干预措施: Cefazolin (Drug)
Intravenous
One single dose of intravenous Cefazolin 1000 mg one hour before catheter insertion
干预措施: Cefazolin (Drug)
结局指标
主要结局
Peritonitis
时间窗: 14 days
Peritonitis asscociated catheter defined by cloudy effluent, high leukocyte count with neutrofilia
次要结局
- Exit site infection(14 days)
- Tunnel infection(14 days)
研究者
Victor Frajewicki, MD
Head, Department of Nephrology and Hypertension
Carmel Medical Center
