Comparison of Two Extracorporeal Liver Support System (With or Without Recirculation) : MARS (Molecular Adsorbents Recirculating System) Versus SPAD (Single Pass Albumin Dialysis) in Severe Liver Failure.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Comparison of total plasmatic bilirubin level before and after two albumin dialysis systems : with recirculation (MARS™ system) and without recirculation (SPAD™ system)
研究概览
简要总结
A critical issue of the clinical syndrome in liver failure is the accumulation of toxins not cleared by the failing liver. Based on this hypothesis, albumin dialysis is used to remove those substances. Albumin dialysis with recirculation (MARS) is the most used system but required specific system and expert environment. Alternative system without recirculation (SPAD) is less expensive and can be realised in critical care services trained to extrarenal epuration. The primary objective of this study is to compare biological and clinical efficacy, pulsatility index of middle cerebral artery modification and tolerance of both systems.
This is a prospective, open, cross-over comparative study of two albumin dialysis system. Each patient will receive the two systems in an randomly assessed order. Patients are divided up according to bilirubin plasmatic level. (250µmol/L to 400 µmol/L and >400µmol/L).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •severe hepatic failure on acute liver failure or acute on chronic liver failure
- •hyperbilirubinemia (total plasmatic bilirubin level above 250µmol/L)
- •hepatic encephalopathy or pruritus or hepatorenal syndrome.
- •waiting for liver function recovery or liver transplantation
- •Signed written informed consent by patient or patient's legally appointed representative or reliable person
- •affiliation to social security
排除标准
- •contraindication to extra-renal epuration
- •hypersensibility to albumin or excipients
- •patients for whom 2 albumin dialysis treatment cannot be considered
研究组 & 干预措施
MARS-SPAD
Patients will receive first the MARS albumin dialysis system and then, in a second time, the SPAD albumin dialysis system.
干预措施: MARS albumin dialysis system (Device)
MARS-SPAD
Patients will receive first the MARS albumin dialysis system and then, in a second time, the SPAD albumin dialysis system.
干预措施: SPAD albumin dialysis system (Device)
SPAD-MARS
Patients will receive first the SPAD albumin dialysis system and then, in a second time, the MARS albumin dialysis system.
干预措施: MARS albumin dialysis system (Device)
SPAD-MARS
Patients will receive first the SPAD albumin dialysis system and then, in a second time, the MARS albumin dialysis system.
干预措施: SPAD albumin dialysis system (Device)
结局指标
主要结局
Comparison of total plasmatic bilirubin level before and after two albumin dialysis systems : with recirculation (MARS™ system) and without recirculation (SPAD™ system)
时间窗: Before and at the end of a MARS™ dialysis (8h) and before and at the end of a SPAD™ system dialysis (10h). Participants will be followed for the duration of critical care stay, an expected average of 1 week
Determination of total plasmatic bilirubin level will be performed by arterial sample and expressed in µmol/liter. Total plasmatic bilirubin purification will be compared between the two dialysis systems: total plasmatic bilirubin level will be measured before and at the end of MARS™ dialysis (8 hours) and before and at the end of SPAD™ dialysis (10 hours) ; the two variations will be compared. Each patient will receive the two dialysis systems separated by a free interval that will last between 12 and 48 hours.
次要结局
- Comparison of hepatic encephalopathy score before and after two albumin dialysis systems : with recirculation (MARS™ system) and without recirculation (SPAD™ system)(Before and at the end of a MARS™ system dialysis (8h) and before and at the end of a SPAD™ system dialysis (10h) . Participants will be followed for the duration of critical care stay, an expected average of 1 week.)
- Comparison of bile acids and conjugated bilirubin levels before and after two albumin dialysis systems: with recirculation (MARS™ system) and without recirculation (SPAD™ system).(Before and at the end of a MARS™ system dialysis (8h) and before and at the end of a SPAD™ dialysis (10h) . Participants will be followed for the duration of critical care stay, an expected average of 1 week.)
- Comparison of pulsatility index of middle cerebral artery recorded by transcranial doppler before and after two albumin dialysis system : with recirculation (MARS™ system) and without recirculation (SPAD™ system)(Before and at the end of a MARS™ dialysis (8h) and before and at the end of a SPAD™ system dialysis (10h). Participants will be followed for the duration of critical care stay, an expected average of 1 week)
- Comparison of tolerance of two albumin dialysis sytems : with recirculation (MARS™ system) and without recirculation (SPAD™ system)(During MARS™ system dialysis (8h) and during SPAD™ system dialysis (10h) . Participants will be followed for the duration of critical care stay, an expected average of 1 week.)