Multi-center, prospective, randomised, controlled study to assess the efficacy of Cathasept line lock to reduce microbial colonization of tunneled hemodialysis catheters

Tyco Healthcare Group LP d/b/a Covidien (USA)0 个研究点目标入组 140 人开始时间: 2015年4月2日最近更新: 2016年10月17日

适应症

试验速览

暂无简介。

•1. Able to provide informed consent
•2. History of established renal failure (ERF)
•3. Starting or undergoing hemodialysis using a t-HDC in an internal jugular or subclavian vein

•1. Any medical, social or psychological condition that would compromise participation and follow-up in the study
•2. Females who were pregnant or lactating
•3. Patients who had a tunneled catheter with an expected duration of placement or use of less than 60 days
•4. Patients enrolled in another clinical study, or had participated in the study
•5. Life expectancy of less than 3 months
•6. Patients with existing tunneled central venous catheters who had positive blood cultures or received antimicrobial therapy, including antibiotic lock solution and/or antimicrobial catheters, for documented or suspected CRBSI within 14 days prior to enrolment
•7. Evidence of systemic infection or catheter exit site infection at the time of enrolment
•8. Patients with colonized catheters (screening quantitative through catheter blood cultures (QTCBC) yielding >20 cfu/ml bacteria or yeasts)
•9. Patients whose catheters demonstrated signs of dysfunction in two or more dialysis sessions during the last two weeks prior to enrolment. These signs were defined as:
•9.1. Blood flow rate < 200 ml/min, or prescribed blood flow rate was not achieved, OR
•9.2. Elevated venous pressure (>250 mmHg), or negative arterial pressure of greater than (-250 mmHg), OR
•9.3. Line reversal (using the arterial port to aspirate and the venous port to return blood)
•10. A known sensitivity to heparin, disodium EDTA, or natural rubber latex

发起方

Tyco Healthcare Group LP d/b/a Covidien (USA)