Comparative Study of Two Haemodialysis Catheter Exit Site Dressings: Chlorhexidine Gluconate Dressing vs Chlorhexidine 2% Solution.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 53
- 试验地点
- 2
- 主要终点
- Bacteraemia Rate
研究概览
简要总结
The objective of this study is to compare the rate of hemodialysis catheter-related infections according to the treatment regimen: chlorhexidine gluconate dressing or chlorhexidine solution.
详细描述
Introduction
The use of CVC as a vascular access for haemodialysis is associated with increased morbidity and mortality (up to 10 times higher in a patient with a CVC compared to an arteriovenous fistula), contributing to poorer patient outcomes and increased haemodialysis-related costs.
Aim: To compare the rate of catheter-related infections (bacteraemia, exit site infection and tunelitis) between haemodialysis catheter exit site dressing with 2% chlorhexidine gluconate self-adhesive semi-permeable polyurethane dressings (AGCD); and dressing with 2% chlorhexidine solution and covered with self-adhesive semi-permeable polyurethane dressing (PD).
Methods: A randomized clinical trial will be conducted to compare the occurrence of local and systemic infections related to hemodialysis catheter. Two care groups will be formed in which AGCD and PD dressings will be used. In addition, other clinical variables, patient satisfaction and dressing-related skin alterations will also be analyzed.
Scientific relevance: Infectious complications related with hemodialysis catheter have an increased morbidity, mortality and incremented costs.
Key words: hemodialysis, Central Venous Catheters, Bacteremia, exit site infection, tunnel infection, chlorhexidine gluconate dressing.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be included in the haemodialysis programme in our unit.
- •Being a carrier of a tunneled central venous catheter as vascular access.
- •Remain on haemodialysis treatment for at least 3 months in our unit.
- •Consent to participate in the study.
排除标准
- •Allergy or hypersensitivity to chlorhexidine or intolerance to polyurethane dressing
- •Active catheter-related infection.
结局指标
主要结局
Bacteraemia Rate
时间窗: 3 months
presence of fever (body temperature ≥38°C) together with a positive blood culture , with no other source of infection.
Tunnelitis Rate
时间窗: 3 months
occurrence of inflammatory signs extending beyond 2 cm from the cutaneous exit site and into the subcutaneous tract of the catheter (tunnelitis). It may or may not be associated with fever and bacteraemia, and may be accompanied by purulent exudate through the cutaneous exit site.
Exit Site Infection Rate
时间窗: 3 months
positive culture of pericatheter smear together with presence of inflammatory signs limited to 2 cm around the cutaneous exit site, without upper extension towards the catheter cuff.
次要结局
- Patient Satisfaction Rate(3 months)
- Percentage of Hemodialysis Sessions With Skin Lesions(3 months)
- Percentage of Hemodialysis Sessions With Dressing-related Skin Erythema Rate(3 months)
研究者
Raquel Pelayo Alonso
Head nurse of the Nephrology department, RN.
Hospital Universitario Marqués de Valdecilla