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临床试验/NCT03046511
NCT03046511招募中3 期

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

Carmel Medical Center1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2017年3月8日最近更新:
适应症
干预措施

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

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

Experimental

One single dose of intraperitoneal Cefazolin 1000 mg via the recently inserted peritoneal catheter

干预措施: Cefazolin (Drug)

Intravenous

Active Comparator

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

发起方
Carmel Medical Center
申办方类型
Other
责任方
Principal Investigator
主要研究者

Victor Frajewicki, MD

Head, Department of Nephrology and Hypertension

Carmel Medical Center

研究点 (1)

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