The Effect of Prometheus (R) Liver Support Dialysis on Cerebral Metabolism in Acute Liver Failure
Primary Purpose
Acute Liver Failure, Hepatic Encephalopathy, Intracranial Hypertension
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Prometheus (R) liver support dialysis
CVVHDF (Continuously Veno-Venous Hemodiafiltration)
Sponsored by
About this trial
This is an interventional treatment trial for Acute Liver Failure
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
Sites / Locations
- The liverfailure unit, Department of hepatology, Rigshospitalet
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1
2
Arm Description
Treatment with 6-8 hours of Prometheus (R) liver support dialysis
Treatment with 6-8 hours of CVVHDF
Outcomes
Primary Outcome Measures
treatment effect on cerebral oxidative metabolism (lactate/pyruvate-ratio)
Secondary Outcome Measures
treatment effect on intracranial pressure
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00655304
Brief Title
The Effect of Prometheus (R) Liver Support Dialysis on Cerebral Metabolism in Acute Liver Failure
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 Type
Interventional
2. Study Status
Record Verification Date
July 2010
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Rigshospitalet, Denmark
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Liver Failure, Hepatic Encephalopathy, Intracranial Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Treatment with 6-8 hours of Prometheus (R) liver support dialysis
Arm Title
2
Arm Type
Active Comparator
Arm Description
Treatment with 6-8 hours of CVVHDF
Intervention Type
Device
Intervention Name(s)
Prometheus (R) liver support dialysis
Intervention Description
6-8 hours of dialysis
Intervention Type
Device
Intervention Name(s)
CVVHDF (Continuously Veno-Venous Hemodiafiltration)
Intervention Description
6-8 hours of dialysis with the CVVHDF system PrismaFlex offered by Gambro (Sweden).
Primary Outcome Measure Information:
Title
treatment effect on cerebral oxidative metabolism (lactate/pyruvate-ratio)
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
treatment effect on intracranial pressure
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter N Bjerring, MD
Organizational Affiliation
Department of Hepatology, Rigshospitalet
Official's Role
Principal Investigator
Facility Information:
Facility Name
The liverfailure unit, Department of hepatology, Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
The Effect of Prometheus (R) Liver Support Dialysis on Cerebral Metabolism in Acute Liver Failure
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