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

This study has been completed.
Sponsor:
Information provided by:
Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT00655304
First received: April 3, 2008
Last updated: July 26, 2011
Last verified: July 2010
  Purpose

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
Endpoint Classification: Efficacy Study
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • treatment effect on intracranial pressure [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00655304

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

No publications provided

Responsible Party: Peter Nissen Bjerring, MD, Department of Hepatology, Rigshospitelet, Denmark
ClinicalTrials.gov Identifier: NCT00655304     History of Changes
Other Study ID Numbers: ALFPROM-001, H-KF-2007-0006
Study First Received: April 3, 2008
Last Updated: July 26, 2011
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

Additional relevant MeSH terms:
Hepatic Encephalopathy
Hypertension
Liver Failure
Intracranial Hypertension
Liver Failure, Acute
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases
Brain Diseases, Metabolic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Metabolic Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 16, 2014