Regional Citrate Anticoagulation Versus No-anticoagulation for CRRT in Hyperlactatemia Patients With Increased Bleeding Risk: a Randomized, Control, Open-labeled Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 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 hyperlactatemia patients with increased bleeding risk.
详细描述
For continuous renal replacement therapy (CRRT) patients with shock and muscle hypoperfusion, which characterised by tissue hypoxia and hyperlactatemia, the Kidney Disease Improving Global Outcomes (KIDIGO) guideline recommended no use of regional citrate anticoagulation (RCA) considering the potential increased citrate accumulation (CA) risk. In the condition of increased bleeding, no-anticoagulation was recommended for these patients. However, CRRT processed without anticoagulation was proved to be associated with shorter filter lifespan. Therefore, the purpose of this single center, randomized, control, open-labeled study is to evaluate the safety and efficacy of RCA versus no-anticoagulation for CRRT in hyperlactatemia patients with increased bleeding risk.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age≥16 years
- •Hyperlactatemia (Lactic acid or serum lactate level > 2 mmol/L)
- •Required CRRT
- •Increased bleeding risk: PLT < 40 x 109, aPTT > 60 s, INR > 1.5, bleeding or active bleeding within 7 days, recent trauma or surgery (especially head trauma and neurosurgery), recent stroke, intracranial venous malformation or aneurysm, retinal hemorrhage, uncontrolled hypertension, and epidural catheter implantation.
排除标准
- •Drugs (biguanide, linezolid, cyanide, etc.) and congenital metabolic disorders (glucose-6 phosphatase and 1,6 phosphofructosase deficiency) and mitochondrial damage caused hyperlactatemia.
- •Receiving systemic anticoagulant treatment (heparin/lmol/warfarin/aspirin, etc.) within 24 hours.
- •Critical patients with lactic acid ≥15mmol\L (with a mortality of 100%) were excluded
- •Patients with APTT > 100S were excluded (retrospective data suggested that this type of patients received CRRT treatment should last for more than 24 hours)
- •Patients who are pregnant or during lactation
- •Severe liver failure: child-pugh score >10 (chronic severe liver failure), MELD score > 30 (acute severe liver failure), total bilirubin >51 mol/L
- •Patients with internal fistula were treated with CRRT
- •Unable to cooperate with treatment due to mental problems (such as depression and mental illness)
- •CRRT with arteriovenous fistula, or the prescribed treatment time < 12 hours
结局指标
主要结局
Filter failure
时间窗: 72 hours
TMP (transmembrane pressure) ≥ 300 mmHg, extracorporeal coagulation due to blood clots
次要结局
- Hypocalcemia(72 hours)
- Serum Total Ca2+/ion Ca2+ level(2, 6, 12, 20, 28, 36, 44, 52, 60, and 72 hours)
- Acidosis(72 hours)
- Serum AST level(Every 24 hours up to 72 hours)
- Serum citrate concentration(2, 6, 12, 20, 28, 36, 44, 52, 60, and 72 hours)
- Alkalosis(72 hours)
- Serum total bilirubin level(Every 24 hours up to 72 hours)
- Serum lactate level(2, 6, 12, 20, 28, 36, 44, 52, 60, and 72 hours)
- citrate accumulation(72 hours)
- APTT(Every 24 hours up to 72 hours)
- PT(Every 24 hours up to 72 hours)
- Bleeding(72 hours)
- INR(Every 24 hours up to 72 hours)
- Mortality(Up to 3 months)
研究者
Shiren sun
Professor
Air Force Military Medical University, China