Skip to main content
OpenTrials
Completed

NCT Number: NCT00655304

The Effect of Prometheus (R) Liver Support Dialysis on Cerebral Metabolism in Acute Liver Failure

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Acute Liver Failure Brain Diseases Brain Diseases, Metabolic Central Nervous System Diseases Digestive System Diseases Hepatic Encephalopathy Hepatic Insufficiency Intracranial Hypertension Liver Diseases Liver Failure Liver Failure, Acute Metabolic Diseases Nervous System Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The liverfailure unit, Department of hepatology, Rigshospitalet

Copenhagen, 2100, Denmark

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Prometheus (R) liver support dialysis

Device

6-8 hours of dialysis

CVVHDF (Continuously Veno-Venous Hemodiafiltration)

Device

6-8 hours of dialysis with the CVVHDF system PrismaFlex offered by Gambro (Sweden).

Primary outcomes

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

    Time frame: 24 hours

Secondary outcomes

  1. treatment effect on intracranial pressure

    Time frame: 24 hours

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2010
Study completion
2011
First posted
Apr 9, 2008
Registry last updated
Jul 27, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.