Evaluation of Chlorhexidine Caps for Central Line Associated Blood Stream Infection Prevention in People Needing Hemodialysis: a Pilot Randomised Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Eligibility
研究概览
简要总结
The goal of this clinical trial is to compare a chlorhexidine antimicrobial barrier cap in patients requiring hemodialysis treatment to the standard hemodialysis caps currently used within the Metro North Kidney Health Service.
The main questions to answer are:
- Study Feasibility
- Occurrence of infectious complications related to renal central venous catheters
Participants will be randomly allocated to receive either of the below hemodialysis caps to cover their hemodialysis catheter hub:
- The standard hemodialysis cap used at the Royal Brisbane and Women's Hospital, or
- The intervention hemodialysis cap containing chlorhexidine inside it
Researchers will compare standard and chlorhexidine hemodialysis caps to see if the presence of chlorhexidine improves the occurrance of infectious complications related to the hemodialysis catheter.
详细描述
This study is a single-centre, two-arm, parallel group Randomized Controlled Trial (RCT) to test the effectiveness, safety, impact of device application on health-related quality of life measures, and cost-effectiveness of ClearGuard™ HD antimicrobial barrier caps in patients receiving hemodialysis.
Setting and Sample:
The ECHO-HD will be undertaken at the Metro North Kidney Health Service (MNKHS), Royal Brisbane and Women's Hospital in Queensland, Australia.
Sample Size:
The investigators will recruit 60 patients with 30 patients per arm. The purpose of the pilot study is to assess research project feasibility and inform the design of a large scale powered RCT. Viechtbauer et al. (2015) determined that a sample size of 59 participants is sufficient to detect a problem with a 5% probability of occurrence.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to provide informed consent
- •Kidney failure requiring a tunnelled CVC for treatment (haemodialysis)
- •21 days BSI free
- •No known allergy to chlorhexidine and/or nylon and/or polypropylene.
排除标准
- •Current CLABSI
- •Known allergic to chlorhexidine and/or nylon and/or polypropylene.
- •Patients on an end-of-life pathway
- •People with a cognitive impairment and/or intellectual disability
结局指标
主要结局
Eligibility
时间窗: 12 Months
Study Eligibility as per inclusion/exclusion criteria (≥80% of screened participants will be eligible for study inclusion)
Recruitment
时间窗: 12 Months
Participant Recruitment onto study (≥80% of eligible participants will provide informed consent to participate in the study)
Fidelity
时间窗: 12 Months
Protocol fidelity of study participants (≥80% will receive the allocated intervention)
Missing data
时间窗: 12 Months
Missing data for primary outcome (\<5% of primary outcome data will be unable to be collected).
次要结局
- Central Line Associated Blood Stream Infection (CLABSI) Rates(12 months with 3 month follow up)
- Catheter Related Infections(12 months with 3 month follow up)
- Central Venous Catheter (CVC) Failure(12 months with 3 month follow up)
- Antibiotic Use(12 months with 3 month follow up)
- Health-related quality of life scores(12 months with 3 month follow up)