NCT01079104终止不适用
Hepa Wash Treatment of Patients With Hepatic Dysfunction in Intensive Care Units
Hepa Wash GmbH2 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2010年9月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- 30-day mortality rate
研究概览
简要总结
Patients with hepatic dysfunction are known to have a high 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 hepatic dysfunction in the intensive care unit.
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
- •Bilirubin ≥ 2 mg/dl AND
- •SOFA-score ≥ 9 calculated 12 hours after initiating medical resuscitation measures AND
- •Patient is in the intensive care unit AND
- •Signed informed consent of the patient or legal representative AND
- •Patients are 18 years or older AND
- •Enrollment of patients within 96 hours of fulfilling inclusion criteria (1-3).
排除标准
- •Patient with known history of chronic liver disease
- •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
- •Patients on kidney dialysis
- •Patients 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
Control
Active Comparator
Standard Medical Therapy
干预措施: Standard Medical Therapy (Procedure)
Hepa Wash
Experimental
Treatment with the liver support system "Hepa Wash"
干预措施: Hepa Wash (Device)
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
- Multiorgan system failure according to the Sequential Organ Failure Assessment (SOFA) Score(72 hours)
- Number of days without extracorporeal treatment(30 days)
- Adverse Events(30 days)
- 180d-mortality rate(180 days)
- Number of days on ventilation(30 days)
- 1y-mortality rate(1 year)
研究者
研究点 (2)
Loading locations...
相似试验
终止
不适用
Hepa Wash Treatment of Patients With Acute-on-Chronic Liver Failure in Intensive Care UnitsAcute on Chronic Hepatic FailureNCT01079091Hepa Wash GmbH14
已完成
不适用
TheraSpheres Treatment for Unresectable Hepatocarcinoma and Portal Vein ThrombosisPortal Vein ThrombosisLiver CancerNCT01556282Emory University35
招募中
不适用
BActeriophages To Treat Liver Disease Eliminating Harmful Bacteria (BATTLE)Alcoholic HepatitisNCT05618418Copenhagen University Hospital, Hvidovre30
已完成
不适用
Deferasirox for patients with advanced hepatocellular carcinoma : pilot studyadvanced hepatocellular carcinomaJPRN-UMIN000013451Yamaguchi University School of Medicine15
已完成
不适用
HEpatic Regeneration With COupled Plasma Filtration and Adsorption for Liver Extracorporeal DetoxificationLiver Failure, AcuteLiver Failure, Acute on ChronicNCT03312036IRCCS Azienda Ospedaliero-Universitaria di Bologna12