Citrate Versus Heparin for the Lock of Non-tunneled Hemodialysis Catheters in Patients Hospitalised in ICU = Multicentre, Controlled, Randomised Superiority Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 405
- 试验地点
- 1
- 主要终点
- Duration of event-free survival of the first non-tunneled hemodialysis catheter (defined at the time in days from catheter insertion to withdrawal whatever the reason)
研究概览
简要总结
After obtaining written informed consent and inclusion, patients will be randomised into 2 groups for the type of dialysis catheter lock:
- The first group will have a citrate lock
- The second group will have a heparin lock Patients will be stratified according to the centre and type of Renal Replacement Therapy (RRT) continuous or intermittent.
The daily surveillance of patients will not be different from the usual surveillance of patients on Renal Replacement Therapy.
The hemodialysis catheters used will be specific Renal Replacement Therapy catheters.
The decision to withdraw the catheter will be made by the investigator and based on clinical criteria (complications related to the catheter, termination of Renal Replacement Therapy…)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged > 18 years
- •Requiring RRT for acute renal insufficiency
- •For which a 1st non-tunneled catheter is placed
- •In the jugular or femoral position
- •After written informed consent has been obtained from the patient, a member of the family or a person of trust
排除标准
- •Patient presenting active poorly controlled bleeding
- •Known allergy to citrate
- •Acute liver failure (Prothrombin level <30%)
- •Thrombopenia < 30 000/mm3
- •Known or suspected heparin-induced thrombopenia
- •Known systemic bacterial infection at the time the catheter is placed
- •catheter in the subclavicular position
- •Persons not affiliated to a national health insurance scheme
- •Pregnant women
- •Adults under guardianship
研究组 & 干预措施
Heparin lock
干预措施: unfractionated heparin (Drug)
Citrate lock
干预措施: Citrate 4% (Drug)
结局指标
主要结局
Duration of event-free survival of the first non-tunneled hemodialysis catheter (defined at the time in days from catheter insertion to withdrawal whatever the reason)
时间窗: up to 28 days
次要结局
未报告次要终点