Hepa Wash Treatment of Patients With Acute-on-Chronic Liver Failure in Intensive Care Units
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- 30-day mortality rate
研究概览
简要总结
Patients with compensated chronic liver disease who have an episode of acute deterioration of liver function (acute-on-chronic liver failure) are known to have up to 90% mortality rate. Hepa Wash(R) is a newly developed liver and renal support system that is based on the use of recycled albumin dialysate. The new system has shown a high detoxification capacity in in-vitro and preclinical studies. The aim of the study is to evaluate the safety and efficacy of the Hepa Wash system in patients with acute-on-chronic liver failure in the intensive care unit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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 with documented clinical or histological evidence of cirrhosis AND
- •Acute decompensation in previously stable cirrhotic liver disease AND
- •Bilirubin ≥ 2 mg/dl AND
- •SOFA ≥ 9 calculated after 12 hours of optimal medical therapy AND
- •Patient is in the intensive care unit AND
- •Informed consent of the patient or the legal representative AND
- •Patients are 18y or older AND
- •Enrollment of patients within 96 hours of fulfilling inclusion criteria (1-5)
排除标准
- •Untreatable extrahepatic cholestasis
- •Patient has a survival prognosis of less than 6 weeks because of a chronic disease (e.g. metastasizing cancer) and before the acute event which lead to the ICU admission.
- •PaO2/FIO2 ≤ 100 mmHg (respiratory SOFA-score of 4)
- •Patients who receive a vasopressor support of Dopamine >15 µg/kg/min or epinephrine >0.1 µg/kg/min or norepinephrine >0.1 µg/kg/min (cardiovascular SOFA-score of 4)
- •Patients with creatinine ≥5 mg/dl or urine output <200 ml/day (renal SOFA-score of 4)
- •Patients on kidney dialysis
- •Patient with MELD-score of 40
- •Mean arterial pressure ≤ 50 mmHg despite conventional medical treatment
- •Patient testament excludes the use of life-prolonging measures
- •Post-operative patients whose liver failure is related to liver surgery
- •Uncontrolled seizures
- •Active or uncontrolled bleeding
- •Weight ≥ 120 kg
- •Patient diagnosed with Creutzfeldt-Jakob disease
- •Participation in another clinical study
研究组 & 干预措施
ADVOS (Hepa Wash)
Treatment with the liver support system "Hepa Wash"
干预措施: ADVOS (Hepa Wash) (Device)
ADVOS (Hepa Wash)
Treatment with the liver support system "Hepa Wash"
干预措施: Standard Medical Therapy (Procedure)
结局指标
主要结局
30-day mortality rate
时间窗: 30 days
Mortality 30 days after the first intervention
次要结局
- 180d-mortality rate(180 days)
- 1y-mortality rate(1 year)
- Number of days on ventilation(30 days)
- Safety (adverse events and surrogate parameters)(30 days)
- Multiorgan system failure according to Sequential Organ Failure Assessment (SOFA) Score(72 hours)
- Number of days without extracorporeal treatment(30 days)