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

Sponsored by:	Rigshospitalet, Denmark
Information provided by:	Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:	NCT00655304

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)

MedlinePlus related topics: High Blood Pressure

U.S. FDA Resources

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

Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:

treatment effect on cerebral oxidative metabolism (lactate/pyruvate-ratio) [ Time Frame: immediate ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

treatment effect on intracranial pressure [ Time Frame: immediate ] [ Designated as safety issue: No ]

Estimated Enrollment:	12
Study Start Date:	March 2007
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Treatment with 6-8 hours of Prometheus (R) liver support dialysis	Device: Prometheus (R) liver support dialysis 6-8 hours of dialysis
2: Active Comparator 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

Contacts

Contact: Peter N Bjerring, MD

45-3545-9882

peter.nissen.bjerring@rh.hosp.dk

Locations

Denmark
The liverfailure unit, Department of hepatology, Rigshospitalet	Recruiting
Copenhagen, Denmark, 2100
Principal Investigator: Peter N Bjerring, MD

Sponsors and Collaborators

Rigshospitalet, Denmark

Investigators

Principal Investigator:

Peter N Bjerring, MD

Department of Hepatology, Rigshospitalet

More Information

Responsible Party:	Department of Hepatology, Rigshospitelet, Denmark ( Peter Nissen Bjerring, MD )
Study ID Numbers:	ALFPROM-001, H-KF-2007-0006
Study First Received:	April 3, 2008
Last Updated:	April 4, 2008
ClinicalTrials.gov Identifier:	NCT00655304
Health Authority:	Denmark: The Danish National Committee on Biomedical Research Ethics

Study placed in the following topic categories:

Liver Failure
Liver Diseases
Metabolic Diseases
Vascular Diseases
Pseudotumor Cerebri
Central Nervous System Diseases
Brain Diseases
Intracranial Hypertension

Pseudotumor cerebri
Hepatic Encephalopathy
Digestive System Diseases
Liver Failure, Acute
Metabolic disorder
Hypertension
Hepatic Insufficiency
Brain Diseases, Metabolic

Additional relevant MeSH terms:

Nervous System Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009