The Efficacy and Safety of Regional Citrate Anticoagulation Versus No-anticoagulation for CRRT in Patients With Liver Failure and High Risk Bleeding: a Randomized, Control, Open-labeled Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Filter failure
研究概览
简要总结
The purpose of this single center, randomized, control, open-labeled study is to evaluate the effect and safety of RCA versus no anticoagulation for CRRT in patients with liver failure and high risk bleeding.
详细描述
Liver failure (LF) is a common co-morbidity in critical care patients who need continuous renal replacement therapy (CRRT). Patients with LF are usually associated with impaired coagulation, impaired metabolic ability of anticoagulants, and increased bleeding risk. KDIGO guideline recommended no-anticoagulation for CRRT in patients with liver failure and increased bleeding risk. However, the averaged CRRT circuit lifespan under no-coagulation was reported to be 7-8 hours in patients with liver failure. Commonly, a CRRT regimen needs more than 24 hours treatment, which means 3-4 filters replacement for one regimen in liver failure patients underwent no-anticoagulation CRRT. Several observational studies suggested that regional citrate anticoagulation (RCA) during CRRT was effective and safe in patients with liver failure. Therefore, the current opinions on the anticoagulation strategy for CRRT in patients with liver failure and high bleeding risk are controversial. Therefore, the purpose of this single center, randomized, control, open-labeled study is to evaluate the effect and safety of RCA versus no anticoagulation for CRRT in patients with liver failure and high risk bleeding.
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
- 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
- •Liver failure (acute liver failure and chronic liver failure)
- •High bleeding risk
- •Scheduled CRRT treatment
- •Informed consent
排除标准
- •Use of other anticoagulants
- •Uncorrectable hypoxemia (PaO2 < 60 mmHg) or systemic hypoperfusion shock
- •Pregnancy or lactation
- •Fistula, CRRT treatment time < 12 hours
研究组 & 干预措施
No-anticoagulation
Patients accepted no-anticoagulation CRRT. Blood flow 200 ml/h. The replacement fluid was infused 50% predilution and 50% post-dilution at the speed of 2 L/h.
干预措施: No-anticoagulation (Other)
Regional citrate anticoagulation
Patients accepted regional citrate anticoagulation. Blood flow 120-220 ml/h. Sodium citrate (4%) infusion before the filter in order to maintain post-filter ionCa2+ level between 0.25 to 0.35 mmol/L. Calcium gluconate supplementary after the filter to maintain serum ionCa2+ level between 1.0 to 1.2 mmol/L.
Adjusting the infusion rate of sodium citrate and blood flow according to pre- and post-filtration ionCa2+.
Adjusting the infusion rate of calcium gluconate according to the serum ionCa2+ level.
干预措施: Regional citrate anticoagulation (Other)
结局指标
主要结局
Filter failure
时间窗: 72 hours
Filter failure
次要结局
- Acidosis(72 hours)
- Hypocalcemia(72 hours)
- Alkalosis(72 hours.)
- Serum Total Ca2+/ion Ca2+ level(2, 6, 12, 20, 28, 36, 44, 52, 60, and 72 hours.)
- Serum citrate concentration(2, 6, 12, 20, 28, 36, 44, 52, 60, and 72 hours.)
- Bleeding(72 hours)
- Serum AST level(Every 24 hours up to 72 hours.)
- Serum ALT level(Every 24 hours up to 72 hours.)
- Serum total bilirubin level(Every 24 hours up to 72 hours.)
研究者
Shiren sun
Professor
Air Force Military Medical University, China