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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00655304
Recruitment Status : Completed
First Posted : April 9, 2008
Last Update Posted : July 27, 2011
Sponsor:
Information provided by:
Rigshospitalet, Denmark

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Acute Liver Failure Hepatic Encephalopathy Intracranial Hypertension Device: Prometheus (R) liver support dialysis Device: CVVHDF (Continuously Veno-Venous Hemodiafiltration) Not Applicable

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).

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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
Study Start Date : March 2007
Actual Primary Completion Date : December 2010
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

Arms and Interventions
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Arm Intervention/treatment
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).


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

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

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00655304


Locations
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Denmark
The liverfailure unit, Department of hepatology, Rigshospitalet
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
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Principal Investigator: Peter N Bjerring, MD Department of Hepatology, Rigshospitalet
More Information
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Responsible Party: Peter Nissen Bjerring, MD, Department of Hepatology, Rigshospitelet, Denmark
ClinicalTrials.gov Identifier: NCT00655304    
Other Study ID Numbers: ALFPROM-001
H-KF-2007-0006
First Posted: April 9, 2008    Key Record Dates
Last Update Posted: July 27, 2011
Last Verified: July 2010
Additional relevant MeSH terms:
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Liver Failure
Hepatic Insufficiency
Hepatic Encephalopathy
Liver Failure, Acute
Brain Diseases
Intracranial Hypertension
 Central Nervous System Diseases
Nervous System Diseases
Liver Diseases
Digestive System Diseases
Brain Diseases, Metabolic
Metabolic Diseases