Evaluation of the Efficacy of Prophylactic Topical Gentamicin in Tunnelled Catheters for Hemodialysis: a Randomized, Double-blind Clinical Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Rates of exit-site infection
研究概览
简要总结
Chronic kidney disease (CKD) is a major public health problem worldwide, with a significant increase in the number of patients treated with dialysis and renal transplantation. Hemodialysis (HD) is the most widely used dialysis therapy in the world, and adequate vascular access is required. The central venous catheter (CVC), although not considered the ideal vascular access, is still widely used. Its use has a strong relation with access-related infection, whether it is an exit orifice (IES), a tunnel and the most severe, the bloodstream (BSI). Consequently CVC contributes to patients' morbidity and mortality in HD, as well as to the high cost of hemodialysis treatment.
To compare the use of 0.1% topical gentamicin with the use of placebo in the exit site (ES) of tunneled catheters in patients in chronic HD regarding the reduction in IES and BSI rates and to identify the induction of bacterial resistance to gentamicin.
详细描述
A randomized, double-blind clinical trial comparing the use of 0.1% gentamicin versus placebo in the ES of tunnelled catheters for hemodialysis in the prevalence and density of incidence of IES and BSI. Patients will be allocated into two groups randomly: Group 1 (control): Patients using placebo ointment in ES; Group 2 (intervention): Patient using 0.1% gentamicin ointment in ES.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Patients will be allocated to two groups randomly (draw), according to the prescribed topical treatment (gentamicin or placebo). The randomization protocol will be generated by an individual other than the patients' clinical follow-up using specific software (randomization). . The randomization list as well as the identification of the bottles and the uniformity of the packages will remain under the care of the researchers who are not familiar with the patients' clinical follow-up
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •patients under 18 years of age
- •pregnant women
- •other types of access for dialysis other than tunnelled catheters
- •course of infection at the time of initiation of the study.
研究组 & 干预措施
Group 1 (control):
Patients using placebo ointment at the exit site of the hemodialysis catheter
干预措施: Placebo (Drug)
Group 2 (intervention)
Patient using 0.1% gentamicin ointment at the exit site of the hemodialysis catheter
干预措施: 0.1% gentamicin (Drug)
结局指标
主要结局
Rates of exit-site infection
时间窗: 1 years
Rates of exit-site infection (measured in events per 1,000 catheter-days)
Rates of catheter-related bloodstream infections
时间窗: 1 years
Rates of catheter-related bloodstream infections (measured in events per 1,000 catheter-days)
次要结局
未报告次要终点
研究者
Camille Pereira Caetano
Principal Investigator
Universidade Estadual Paulista Júlio de Mesquita Filho