The Effect of Prometheus (R) Liver Support Dialysis on Cerebral Metabolism in Acute Liver Failure
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|ClinicalTrials.gov Identifier: NCT00655304|
Recruitment Status : Completed
First Posted : April 9, 2008
Last Update Posted : July 27, 2011
|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|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|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|
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).
- treatment effect on cerebral oxidative metabolism (lactate/pyruvate-ratio) [ Time Frame: 24 hours ]
- treatment effect on intracranial pressure [ Time Frame: 24 hours ]
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
|The liverfailure unit, Department of hepatology, Rigshospitalet|
|Copenhagen, Denmark, 2100|
|Principal Investigator:||Peter N Bjerring, MD||Department of Hepatology, Rigshospitalet|