The Effect of Prometheus (R) Liver Support Dialysis on Cerebral Metabolism in Acute Liver Failure
|Acute Liver Failure Hepatic Encephalopathy Intracranial Hypertension||Device: Prometheus (R) liver support dialysis Device: CVVHDF (Continuously Veno-Venous Hemodiafiltration)|
|Study Design:||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|
- treatment effect on cerebral oxidative metabolism (lactate/pyruvate-ratio) [ Time Frame: 24 hours ]
- treatment effect on intracranial pressure [ Time Frame: 24 hours ]
|Study Start Date:||March 2007|
|Study Completion Date:||June 2011|
|Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
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).
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00655304
|The liverfailure unit, Department of hepatology, Rigshospitalet|
|Copenhagen, Denmark, 2100|
|Principal Investigator:||Peter N Bjerring, MD||Department of Hepatology, Rigshospitalet|