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NCT00655304 Clinical Trial

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

Hepatic Encephalopathy Clinical Trial

Official title:
The Effect of Prometheus (R) Liver Support Dialysis on Intracranial Pressure, Cerebral Oxidative Metabolism and Hemodynamics in Patients With Acute Liver Failure

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00655304
Other study ID # ALFPROM-001
Secondary ID H-KF-2007-0006
Status Completed
Phase N/A
First received April 3, 2008
Last updated July 26, 2011
Start date March 2007
Est. completion date June 2011

Study information
Verified date July 2010
Source Rigshospitalet, Denmark
Contact n/a
Is FDA regulated No
Health authority Denmark: The Danish National Committee on Biomedical Research Ethics
Study type Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility
Status Completed
Enrollment 8
Est. completion date June 2011
Est. primary completion date December 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• Prometheus (R) liver support dialysis
6-8 hours of dialysis
• CVVHDF (Continuously Veno-Venous Hemodiafiltration)
6-8 hours of dialysis with the CVVHDF system PrismaFlex offered by Gambro (Sweden).

Locations
Country Name City State
Denmark The liverfailure unit, Department of hepatology, Rigshospitalet Copenhagen

Sponsors (1)
Lead Sponsor Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary treatment effect on cerebral oxidative metabolism (lactate/pyruvate-ratio) 24 hours No
Secondary treatment effect on intracranial pressure 24 hours No
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