Comparison of an Intensive Versus a Standard Hemodialysis Central Venous Catheter Dysfunction Protocol Using Alteplase
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Alteplase use
研究概览
简要总结
Central venous catheters (CVCs) are used for vascular access by approximately 56% of our 380 hemodialysis (HD) patients at the Capital Health Renal Program. The major complication of these catheters includes thrombosis and infection. Catheter locking solutions such as recombinant tissue plasminogen activator (rt-PA), Alteplase (Cathflo®) are used to treat and prevent clotting of the catheter during HD treatments and during the interdialytic period. Evidence to guide the use of rt-PA is limited. This quality assurance project will compare the effectiveness and cost of an intensive versus a standard catheter dysfunction protocol for rt-PA in HD patients.
详细描述
The proposed study will be a retrospective cohort study of consecutive HD patients conducted at a HD unit using two catheter dysfunction protocols during January 2013 to Septebmer 2013. In the Intensive Protocol, rt-PA intervention is administered to all catheters based on blood flow and/or line reversal. In the Standard Protocol, rt-PA intervention is administered to all catheters based only on blood flow.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All adults undergoing HD with a tunneled CVC (both newly inserted CVCs as well as pre-existing CVCs) will be included.
排除标准
- •Patients were excluded from using the CVC dysfunction protocols if they had a known allergy or intolerance to rt-PA.
- •A physician order to proceed with the CVC dysfunction protocols was required if they met one of the following criteria:
- •CVC line insertion or exchange within 72 hours;
- •any surgery, organ biopsy, obstetrical delivery within 72 hours;
- •active bleeding; bleeding disorders; hemoglobin decrease greater than 20 g/L over 2 weeks;
- •active pericarditis; arterial puncture within 48 hours;
- •bacteremia with positive blood cultures.
研究组 & 干预措施
Intensive
In the Intensive Protocol, alteplase intervention is administered to all catheters based on blood flow and/or line reversal
干预措施: Alteplase (Drug)
Standard
In the Standard Protocol, alteplase intervention is administered to all catheters based only on blood flow.
干预措施: Alteplase (Drug)
结局指标
主要结局
Alteplase use
时间窗: 9 months
Incident rate of rt-PA uses includes the numerator which will consist of the number of HD sessions during which a patient was administered rt-PA for catheter malfunction and the denominator will be the time period at risk in catheter days.
次要结局
- Cost of alteplase(9 months)
- Rate of bacteremia(9 months)