The Impact of Central-line Exit-site Sealing With 2-octyl Cyanoacrylate Adhesive on CLABSI in Pediatric Cardiac Intensive Care Unit
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 600
- 试验地点
- 2
- 主要终点
- CLABSI rate
研究概览
简要总结
Our aim is to test the effect of tissue adhesive application at the Central-line exit-site on CLABSI rates in high-risk pediatric congenital heart disease patients.
详细描述
Health-care associated infections (HAI) and especially central-line associated blood stream infections (CLABSI) are a well described burden in the intensive care units. There are two main possible pathways leading to central-venous line (CVL) related infection: the first is migration of microbes down the catheter tract (between the CVL and the skin), and the second is via the catheter hub/lumen. Cyanoacrylate adhesive is a commonly used tissue adhesive in children and adults with frequent use in pediatric facial lacerations. Several studies have shown its feasibility and safety in the general pediatric population, including neonates and in children after cardiac surgery.
To our knowledge, no study to date has explored the use of 2-octyl cyanoacrylate at central-line exit site as a mean to decreases pediatric CLABSI.
Our aim is to assess 2-octyl cyanoacrylate association with CLABSI rate in pediatric cardiac intensive care population.
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
- 0 Days 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients admitted to pediatric cardiac ICU (PCICU) defined as high-risk for CLABSI (any of):
- •young age<1y & Congenital Heart Surgery Mortality Category (STAT\STS-EACTS) score 2-5
- •Risk Adjustment for Congenital Heart Surgery (RACHS) category ≥3
- •preoperative length-of-stay (LOS) >7 days
- •preoperative ventilator support
- •presence of a genetic abnormality
- •extracorporeal membrane oxygenation (ECMO) support
排除标准
- •Patients with on-going bacteremia
- •patients with pre-existing central-line or peripherally inserted central catheter (PICC)
- •parental refusal to participate.
结局指标
主要结局
CLABSI rate
时间窗: up to 1 year
次要结局
- invasive mechanical ventilation duration(up to 1 year)
- Postoperative ECMO support(up to 1 year)
- dressing changes rates(average of 14 days)
- safety outcome: Number pf participants with contact dermatitis at the catheter exit site, line dislodgement, leak, exit site bleeding, allergic reaction or line tunnel infection(average of 14 days)
- presence of lung atelectasis(up to 1 year)
- ICU LOS(up to 1 year)
- Chylothorax(up to 1 year)
- Extubation failure(up to 1 year)
- multidrug resistant bacterial colonization(up to 1 year)
- Chest drains duration(up to 1 year)
- need for cardiopulmonary resuscitation (CPR)(up to 1 year)
- mortality rate(up to 1 year)
研究者
ERAN SHOSTAK
Principal Investigator
Rabin Medical Center