Regional Citrate Anticoagulation for Continuous Renal Replacement Therapy During Veno-venous ECMO: a Crossover Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Incidence of CRRT circuit clotting according to anticoagulation regimen
研究概览
简要总结
Anticoagulation is an essential component of all extracorporeal therapies. Currently locoregional citrate anticoagulation is the recommended technique for continuous renal replacement therapy (CRRT).
However, low clearance of citrate restricts its use to blood flow up to 150 mL/min, preventing its use in ECMO.
Renal replacement therapy (RRT) is commonly provided to ECMO patients with AKI. In presence of systemic heparinization for ECMO, additional anticoagulation for the CRRT circuit (i.e. RCA) is usually not employed.
Nevertheless, thrombosis occurs more frequently in the CRRT circuit than the oxygenator because of the slower blood flow.
The aim of this prospective, cross-over study is to assess, in patients undergoing CRRT during veno-venous ECMO (vv-ECMO), the efficacy and safety of adding regional citrate anticoagulation (RCA) for CRRT circuit anticoagulation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
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 admitted in ICU
- •V-V ECMO support for acute respiratory failure
- •CRRT therapy for acute kidney injury
排除标准
- •Pregnancy
- •Pre-existing coagulation disorders
- •Contraindication to heparin or citrate anticoagulation
- •Moribund patients
研究组 & 干预措施
Anticoagulation sequence 1 (UFH+ RCA)
UFH+ RCA first
干预措施: Unfractionated heparin first (Drug)
Anticoagulation sequence 2 (UFH)
UFH first
干预措施: Unfractionated heparin + RCA first (Drug)
结局指标
主要结局
Incidence of CRRT circuit clotting according to anticoagulation regimen
时间窗: According to the manufacturer recommendation elective RRT circuit replacement will be performed after 72 hours of circuit life.
Rate of clotting in the intervention group (RCA+UFH) vs controls (UFH). I.e. : did the circuit clot in its 72h life?
次要结局
- CRRT circuit "survival" analysis(According to the manufacturer recommendation elective RRT circuit replacement will be performed after 72 hours of circuit life.)
- Comparison of platelets count, D-dimers, fibrinogen(72 hours for each circuit)
- Incidence of citrate anticoagulation side-effects(72 hours for each circuit)
- To evaluate the anticoagulation effects of UFH and RCA(72 hours for each circuit)
研究者
Marco Giani
Research Collaborator
University of Milano Bicocca