Control of Line Complications With KiteLock (CLiCK) in the Critical Care Unit
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,449
- 试验地点
- 7
- 主要终点
- Primary Composite Outcome of CVAD Complications Modifiable by Lock Procedures
研究概览
简要总结
Insertion of a central venous access device (CVAD) allows clinicians to easily access the circulation of a patient to administer life-saving interventions. Due to their invasive nature, CVADss are prone to complications such as infection, bacterial biofilm production, and catheter occlusion due to a thrombus. A CVAD is placed in up to 97% of patients in the intensive care unit, exposing this vulnerable population to risk of nosocomial infection and occlusion.
Current standard of care involves use of normal saline (for CVCs and PICCs) or citrate (for hemodialysis catheters) as a catheter locking solution. CVAD complications remain a problem with current standard of care.
4% tetrasodium Ethylenediaminetetraacetic acid (EDTA) fluid (KiteLock Sterile Locking Solution) possesses antimicrobial, anti-biofilm, and anti-thrombotic properties and is approved by Health Canada as a catheter locking solution. As such, it may be superior CVC locking solution than the present normal saline or citrate lock.
To our knowledge, the efficacy of an EDTA catheter locking solution has not yet been investigated in the intensive care patient population. Our team proposes to fill this knowledge gap by performing a multi-centre, cluster-randomized, crossover study evaluating the impact of KiteLock Sterile Locking Solution on a primary composite outcome of CLABSI, intraluminal occlusion, and alteplase use in the ICU of six ICU's compared to the standard of care saline lock.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>18 years of age ICU/HAU Admission
- •Presence of a central venous catheter requiring locking. This includes CVCs, IVADs, dialysis lines, and PICC lines.
排除标准
- •Known or tested sensitivity to EDTA or edetate
- •Confirmed or suspected pregnancy
- •Patients who decline receiving blood products
- •Physician, patient, or temporary substitute decision maker (TSDM) declines
- •Currently enrolled in any other research study that may confound primary outcome measures. Co-enrollment in multiple studies will be considered on an individual basis
- •Patients who were previously enrolled in the study. Patients who were enrolled in the first period are not eligible for (re-)enrolment in the second period, and patients who are enrolled in the study and transferred to another participating hospital are not eligible for (re-)enrollment at the receiving hospital. Patients who had been discharged from the unit to another hospital ward and are re-admitted to the critical care unit are no eligible for re-enrollment into the study.
结局指标
主要结局
Primary Composite Outcome of CVAD Complications Modifiable by Lock Procedures
时间窗: From date of randomization until the date of catheter removal, ICU discharge, patient death death, or through study completion, an average of 9 months.
incidence rate of the following: catheter obstruction requiring Alteplase, central-line associated bloodstream infection (CLABSI), or CVC replacement due to occlusion.
次要结局
- Incidence rate of catheter occlusion requiring removal(From date of randomization until the date of catheter removal, ICU discharge, patient death death, or through study completion, an average of 9 months)
- Incidence rate of catheter colonization(From date of randomization until the date of catheter removal, ICU discharge, patient death death, or through study completion, an average of 9 months)
- Incidence rate of confirmed/suspected CLABSI(From date of randomization until the date of catheter removal, ICU discharge, patient death death, or through study completion, an average of 9 months)
- Incidence rate of catheter obstruction requiring alteplase use(From date of randomization until the date of catheter removal, ICU discharge, patient death death, or through study completion, an average of 9 months)
- Classification of microbial species isolated from colonized catheters(From date of randomization until the date of catheter removal, ICU discharge, patient death death, or through study completion, an average of 9 months)
- Direct cost related to alteplase use for catheter occlusion(through study From date of randomization until the date of catheter removal, ICU discharge, patient death death, or through study completion, an average of 9 months, an average of 16 months)
- Incidence rate of catheter-associated venous thrombosis(From date of randomization until the date of ICU discharge, patient death death, or through study completion, an average of 9 months)
研究者
Steve Reynolds
Critical Care Physician
Fraser Health