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临床试验/NCT03798171
NCT03798171Unknown不适用

Reduction of Exit Site Infection in Peritoneal Dialysis Patients

Tel-Aviv Sourasky Medical Center1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2018年5月15日最近更新:
适应症

试验速览

阶段
不适用
入组人数
80
试验地点
1
主要终点
exit-site infection rate

研究概览

简要总结

In peritoneal dialysis patients, the presence of the catheter presents a risk of infection - exit site infection, tunnel infection or peritonitis. In our dialysis unit, we noticed a rise in exit-site infection associated with organisms derived from contaminated water. Therefore we decided to change the exit-site care in our unit.

This is a prospective observational single center study, that compares exit-site infection rated in peritoneal dialysis patients before and after our policy change for exit-site care.

详细描述

Peritoneal dialysis is a method for renal replacement therapy that uses the peritoneal membrane for exchange of fluids and dissolved substance . A catheter is surgically inserted with one end in the abdomen and the other protruding from the skin, in order to allow fluid exchange.

The presence of the catheter presents a risk of infection - exit site infection, tunnel infection or peritonitis - a cause of morbidity and treatment failure.

Infection prevention is based, among other measures, on aseptic handeling of catheter exit-site. In our dialysis unit, we noticed a rise in pseudomonas exit-site infection and other organisms associated with contaminated water. Therefore we decided to change the exit-site care in our unit. Similar to central catheters handeling, we decided to cover the catheter exit-site during water exposure, and to change the prophylactic exit-site antibiotic regimen.

This is a prospective observational single center study. All peritoneal dialysis patients in our institue will be counseled about change in exit-site care. For prevention of water exposure the patients will use stoma bags around the catheter during showers. After the shower, the exit-site is cleaned with a chlorhexidine based solution, an antibiotic cream is applied (Mupirocin) and dressed with a clean gauze.

The patients will be followed for 3 years for adverse events. The number of infectious episodes will be recorded and compared to historical data (January 2015-December 2017).

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • peritoneal dialysis patients capable to sign an informed consent or have an official guardian

排除标准

  • patient's refusal

结局指标

主要结局

exit-site infection rate

时间窗: 36 months

number of exit-site infection during 3 years of follow up, compared to historical data

次要结局

  • peritonitis rate(36 months)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

michal roll

Department of nephrology

Tel-Aviv Sourasky Medical Center

研究点 (1)

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