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临床试验/NCT05874219
NCT05874219已完成2 期

The Effect of Mupirocin 2% Ointment on the Duration of Stay of Temporary Hemodialysis Catheter Compared to Other Spray Antibiotics

Future University in Egypt1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2023年4月10日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
150
试验地点
1
主要终点
Catheter related infection

研究概览

简要总结

In dialysis centers, many patients are undergoing hemodialysis simultaneously, which facilitates the spread of microorganisms by direct or indirect contact through the devices, equipment, surface contact, and hands of health profession Over time, catheters are prone to higher rates of infection, thrombosis, and central venous stenosis, it has also been shown that catheters are an independent (of infection) inflammatory stressor and lead to increased morbidity .

Catheters are aptly referred to as a bacterial highway, and a biofilm formation around the catheter is often the breeding ground of bacteria and fungi, which can easily spread to the bloodstream Infectious complications are the most serious with regards to patient morbidity and mortality. The incidence could be from 3.8 to5.5 episodes per 1000 days

Migration of micro-organism along the external surface of the catheter is probably the most common route of infection through skin and represents 58% .HD catheter has biofilm formation on their surfaces and this serves as a good reservoir for micro-organisms

Most patients with end stage renal disease (ESRD) starting hemodialysis through hemodialysis catheter about 9 % in Egypt and most of them require several hemodialysis catheters before maturation of arterio -venous fistula and even after stopping it.

详细描述

Patients receiving hemodialysis have a high risk of infection due to the immunosuppressive effects caused by ESRD, comorbidities, inadequate nutrition and the need for maintenance of vascular access for long periods.

The catheters are rightfully the least preferred modality and, in an ideal setting, no patient should have a catheter as access. Despite the perils associated with dialysis catheters, their use has increased to almost 70% incident dialysis initiation with catheters In dialysis centers, many patients are undergoing hemodialysis simultaneously, which facilitates the spread of microorganisms by direct or indirect contact through the devices, equipment, surface contact, and hands of health profession Over time, catheters are prone to higher rates of infection, thrombosis, and central venous stenosis, it has also been shown that catheters are an independent (of infection) inflammatory stressor and lead to increased morbidity Catheters are aptly referred to as a bacterial highway, and a biofilm formation around the catheter is often the breeding ground of bacteria and fungi, which can easily spread to the bloodstream Infectious complications are the most serious with regards to patient morbidity and mortality. The incidence could be from 3.8 to5.5 episodes per 1000 days

Migration of micro-organism along the external surface of the catheter is probably the most common route of infection through skin and represents 58% .HD catheter has biofilm formation on their surfaces and this serves as a good reservoir for micro-organisms

Most patients with end stage renal disease (ESRD) starting hemodialysis through hemodialysis catheter about 9 % in Egypt and most of them require several hemodialysis catheters before maturation of arterio -venous fistula and even after stopping it.

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 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults patients receiving long-term hemodialysis using temporary right internal jugular hemodialysis catheter

排除标准

  • Age below 16
  • Noncompliance patients
  • Mechanical complications

研究组 & 干预措施

Local antibiotic spray

Experimental

Local antibiotic spray (n=75) The intervention Sprayed 1 to 3 times /day for 45 day Neomycin sulphate 165,000 IU + Bacitracin zinc 12,500 IU Bivatracin Spray

干预措施: Local antibiotic spray Neomycin sulphate 165,000 IU + Bacitracin zinc 12,500 IU (Drug)

Mupirocin 2% ointment

Active Comparator

(The standard) 10 mm of mupirocin ointment squeezed directly on to their exit sites from a 15 g tube with an outlet diameter of 5 mm mupirocin 2% ointment

干预措施: Mupirocin 2% ointment (Drug)

结局指标

主要结局

Catheter related infection

时间窗: 45 days

Catheter related infection which will manifest by fever rigor and obligatory remove of the catheter.

次要结局

  • The average duration of HD catheter(45 days)

研究者

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

Doaa Mohamed Salah ElDin Diab ELBohy

Assistant professor

Future University in Egypt

研究点 (1)

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