Regional Citrate Versus Systemic Heparin Anticoagulation for Continuous Renal Replacement Therapy in Critically Ill Patients With Acute Kidney Injury
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 638
- 试验地点
- 31
- 主要终点
- CRRT-filter life span in hours
研究概览
简要总结
The aim of this study is to evaluate the effect of regional citrate anticoagulation within the scope of continuous renal replacement (CRRT) in critically ill patients with acute kidney injury (AKI) on filter life span and 90-day all cause mortality.
详细描述
Purpose of clinical trial:
To evaluate the effect of regional citrate anticoagulation within the scope of continuous renal replacement (CRRT) in critically ill patients with acute kidney injury (AKI) on filter life span and 90-day all cause mortality.
Patient population: critically ill patients with acute kidney injury requiring renal replacement therapy.
Primary objective:
Anticoagulation of the extracorporeal circuit is required in continuous RRT (CRRT). To this date, it is not clear which anticoagulant should be used for CRRT. Regional citrate anticoagulation (RCA) for CRRT in critically ill patients with AKI prolongs filter life span and reduces 90-day all cause mortality by approximately 8% (from 48% to 40%) compared to systemic heparin anticoagulation for CRRT
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Critically ill patients with clinical indication for CRRT (clinical decision to use continuous RRT due to hemodynamic instability)
- •Severe acute kidney injury (KDIGO 3-classification) despite optimal resuscitation
- •At least one of the following conditions
- •Sepsis or septic shock
- •Use of catecholamines (norepinephrine or epinephrine ≥ 0.1 µg/kg/min or norepinephrine ≥ 0.05 µg/kg/min + dobutamine (any dose) or norepinephrine ≥ 0.05 µg/kg/min + vasopressin (any dose) or epinephrine ≥ 0.05 µg/kg/min + norepinephrine ≥ 0.05 µg/kg/min)
- •Refractory fluid overload: worsening pulmonary edema: PaO2/FiO2 < 300 mmHg and/or fluid balance > 10% of body weight)
- •18-90 years old
- •Intention to provide full intensive care treatment for at least 3 days
- •Written informed consent of the patient or the legal representatives or the authorized representative or the inclusion due to an emergency situation
排除标准
- •Patients with increased bleeding risk (e.g. an active bleeding from ulcers in the gastro-intestinal tract, hypertension with a diastolic blood pressure higher than 105 mm Hg, injuries (intracranial hemorrhage, aneurysm of brain arteries) of or surgical procedures on the central nervous system if a heparinization with a target aPTT 45-60 s is not allowed by the treating neurologist or neurosurgeon, severe retinopathies, bleeding into the vitreum, ophthalmic surgical procedures)) or injuries, active tuberculosis; infective endocarditis)
- •Disease or organ damage related with hemorrhagic diathesis (coagulopathy, thrombocytopenia, severe liver or pancreas disease)
- •Dialysis-dependent chronic kidney insufficiency
- •Need of therapeutic systemic anticoagulation
- •Allergic reaction to one of the anticoagulants or ingredients, Heparin-induced thrombocytopenia
- •AKI caused by permanent occlusion or surgical lesion of the renal artery
- •AKI caused by (glomerulo)nephritis, interstitial nephritis, vasculitis or postrenal obstruction
- •Do-not-resuscitate order
- •Hemolytic-uremic syndrome/thrombotic thrombocytopenic purpura
- •Persistent and severe lactate acidosis in the context of an acute liver failure and/or shock
- •Kidney transplant within the last 12 months
- •Pregnancy and nursing period
- •Abortus imminens
- •No hemofiltration machine free for use at the moment of inclusion
- •Participation in another clinical intervention trial in the last 3 months
- •Persons with any kind of dependency on the investigator or employed by the sponsor or investigator
- •Persons held in an institution by legal or official order
研究组 & 干预措施
heparin anticoagulation
Systemic anticoagulation of the continuous renal replacement therapy with heparin.
Dose will be titrated to maintain aPTT (activated partial thromboplastin time) between 45-60s)
干预措施: Heparin (Drug)
citrate anticoagulation
Regional anticoagulation of the continuous renal replacement therapy with citrate.
Target posthemofilter ionized calcium level: 0.25-0.35 mmol/l
干预措施: Citrate (Drug)
结局指标
主要结局
CRRT-filter life span in hours
时间窗: during continuous renal replacement therapy up to 1 year
It will be reported how long the filter will be used during CRRT
Overall survival in a 90day follow-up period
时间窗: 90 days
次要结局
- Hospital length of stay in days(up to 1 year)
- ICU length of stay in days(up to 1 year)
- duration of renal replacement therapy(1 year)
- Bleeding complication(intraoperative)
- Rate of infection(during primary ICU stay up to 1 year)
- Complications of therapy(intraoperative)
- Number of participants with hemodialysis(day 28, 60, 90 and 1 year after start of CRRT)
- Number of patients with administration of red blood cells(intraoperative)
- Major adverse kidney events(day 28, 60, 90 and after 1 year after start of CRRT)
- Recovery of renal function(day 28, 60, 90 and 1 year after start of CRRT)
- Mortality(day 28, 60 and 1-year)