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临床试验/NCT00655304
NCT00655304已完成不适用

The Effect of Prometheus (R) Liver Support Dialysis on Intracranial Pressure, Cerebral Oxidative Metabolism and Hemodynamics in Patients With Acute Liver Failure

Rigshospitalet, Denmark2 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2007年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
8
试验地点
2
主要终点
treatment effect on cerebral oxidative metabolism (lactate/pyruvate-ratio)

研究概览

简要总结

The main objective of this study is to investigate the effect of Prometheus liver support dialysis on intracranial pressure, cerebral metabolism and circulation in patients with acute liver failure.

详细描述

Acute liver failure (ALF) is a highly mortal medical condition often complicated by multiorgan failure. Apart from severe coagulopathy ALF is characterized by onset of hepatic encephalopathy and in many cases intracranial hypertension (ICH) with the risk of cerebral incarceration. The pathogenesis behind ICH is incompletely understood and the therapeutic options are limited. Prometheus (R) liver support dialysis offers a system that apart from regular high-flux hemodialysis to a certain extent is able of removing albumin-bound substances from the patient - a feature that theoretically could benefit patients with ALF.

In this study we intend to investigate the effect of 6-8 hours of Prometheus (R) liver support dialysis on cerebral metabolism, ICH and cerebral bloodflow (CBF) in patients with ALF. The study is designed as a open, prospective and randomized study, where a control-group treated with 6-8 hours of continuously veno-venous hemodiafiltration (CVVHDF) and standard medical treatment (SMT) is compared to the intervention group treated with Prometheus (R) liver support dialysis and SMT. The study is designed as a cross-over study so that included patients will be treated in both groups in a randomized order.

The primary end-points are treatment effect on intracranial pressure, CBF and cerebral oxidative metabolism (lactate/pyruvate-ratio). We use a intracranial monitoring system from Integra/Camino (R) (United States) in combination with CMA microdialysis system and bedside analyzer (CMA-600) (Stockholm, Sweden).

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

入选标准

  • acute liver failure
  • and grade II-IV encephalopathy
  • and persistent raised arterial ammonia-concentration above 150 micromol/L
  • and informed consent from closest relative and general practitioner

排除标准

  • withdrawal of informed consent
  • severe untreated infection
  • active bleeding within 48 hours
  • suspicion of malignant liver disease
  • severe heart insufficiency or middle artery pressure below 60 mmHg in spite of vasoactive therapy
  • pregnant or lactating women
  • disseminated intravascular coagulation
  • clinical suspicion of cerebral damage

结局指标

主要结局

treatment effect on cerebral oxidative metabolism (lactate/pyruvate-ratio)

时间窗: 24 hours

次要结局

  • treatment effect on intracranial pressure(24 hours)

研究者

申办方类型
Other

研究点 (2)

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