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

This study has been completed.
Information provided by:
Rigshospitalet, Denmark Identifier:
First received: April 3, 2008
Last updated: July 26, 2011
Last verified: July 2010
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.

Condition Intervention
Acute Liver Failure Hepatic Encephalopathy Intracranial Hypertension Device: Prometheus (R) liver support dialysis Device: CVVHDF (Continuously Veno-Venous Hemodiafiltration)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effect of Prometheus (R) Liver Support Dialysis on Intracranial Pressure, Cerebral Oxidative Metabolism and Hemodynamics in Patients With Acute Liver Failure

Resource links provided by NLM:

Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • treatment effect on cerebral oxidative metabolism (lactate/pyruvate-ratio) [ Time Frame: 24 hours ]

Secondary Outcome Measures:
  • treatment effect on intracranial pressure [ Time Frame: 24 hours ]

Enrollment: 8
Study Start Date: March 2007
Study Completion Date: June 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Treatment with 6-8 hours of Prometheus (R) liver support dialysis
Device: Prometheus (R) liver support dialysis
6-8 hours of dialysis
Active Comparator: 2
Treatment with 6-8 hours of CVVHDF
Device: CVVHDF (Continuously Veno-Venous Hemodiafiltration)
6-8 hours of dialysis with the CVVHDF system PrismaFlex offered by Gambro (Sweden).

Detailed Description:

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).


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00655304

The liverfailure unit, Department of hepatology, Rigshospitalet
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
Principal Investigator: Peter N Bjerring, MD Department of Hepatology, Rigshospitalet
  More Information

Responsible Party: Peter Nissen Bjerring, MD, Department of Hepatology, Rigshospitelet, Denmark Identifier: NCT00655304     History of Changes
Other Study ID Numbers: ALFPROM-001
Study First Received: April 3, 2008
Last Updated: July 26, 2011

Additional relevant MeSH terms:
Brain Diseases
Liver Failure
Hepatic Encephalopathy
Liver Failure, Acute
Intracranial Hypertension
Central Nervous System Diseases
Nervous System Diseases
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases
Brain Diseases, Metabolic
Metabolic Diseases
Liver Extracts
Hematinics processed this record on June 23, 2017