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

NCT ID: NCT00655304

Last Updated: 2011-07-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-03-31
• Study Completion Date: 2011-06-30

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.

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).

Conditions

Acute Liver Failure; Hepatic Encephalopathy; Intracranial Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Treatment with 6-8 hours of Prometheus (R) liver support dialysis

Group Type: ACTIVE_COMPARATOR

Prometheus (R) liver support dialysis

Intervention Type: DEVICE

6-8 hours of dialysis

2

Treatment with 6-8 hours of CVVHDF

Group Type: ACTIVE_COMPARATOR

CVVHDF (Continuously Veno-Venous Hemodiafiltration)

Intervention Type: DEVICE

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

Interventions

Prometheus (R) liver support dialysis

6-8 hours of dialysis

Intervention Type: DEVICE

CVVHDF (Continuously Veno-Venous Hemodiafiltration)

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

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rigshospitalet, Denmark

OTHER

Sponsor Role: lead

Responsible Party

Department of Hepatology, Rigshospitelet, Denmark

Principal Investigators

Peter N Bjerring, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Hepatology, Rigshospitalet

Locations

The liverfailure unit, Department of hepatology, Rigshospitalet

Copenhagen, , Denmark

Countries

Denmark

Other Identifiers

H-KF-2007-0006

Identifier Type: -

Identifier Source: secondary_id

ALFPROM-001

Identifier Type: -

Identifier Source: org_study_id