Acute Liver FailureNCT00655304
The Effect of Prometheus (R) Liver Support Dialysis on Cerebral Metabolism in Acute Liver Failure
A study testing Prometheus (R) liver support dialysis and CVVHDF (Continuously Veno-Venous Hemodiafiltration) in people with Acute Liver Failure and Hepatic Encephalopathy, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Liver Failure, Hepatic Encephalopathy, Intracranial Hypertension
- What is being tested?
- Prometheus (R) liver support dialysis and CVVHDF (Continuously Veno-Venous Hemodiafiltration)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2007to Jun 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
The liverfailure unit, Department of hepatology, Rigshospitalet
Copenhagen, 2100
About this study
Official title: The Effect of Prometheus (R) Liver Support Dialysis on Intracranial Pressure, Cerebral Oxidative Metabolism and Hemodynamics in Patients With Acute Liver Failure
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.
Read the 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).
- Being tested
- Prometheus (R) liver support dialysis, CVVHDF (Continuously Veno-Venous Hemodiafiltration)
- Medical subject headings
- Liver Failure, Acute, Hepatic Encephalopathy, Intracranial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prometheus (R) liver support dialysisDevice
6-8 hours of dialysis
CVVHDF (Continuously Veno-Venous Hemodiafiltration)Device
6-8 hours of dialysis with the CVVHDF system PrismaFlex offered by Gambro (Sweden).
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Treatment with 6-8 hours of Prometheus (R) liver support dialysis Receives: Device: Prometheus (R) liver support dialysis |
| 2 | Active comparator | Treatment with 6-8 hours of CVVHDF Receives: Device: CVVHDF (Continuously Veno-Venous Hemodiafiltration) |
What is being measured
The primary outcome is the main question the study is designed to answer.
treatment effect on cerebral oxidative metabolism (lactate/pyruvate-ratio)
Measured: 24 hours
Secondary outcomes (1)
treatment effect on intracranial pressure
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2008 (estimated)
- Study startMar 2007
- Primary completionDec 2010
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Liver FailureStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Investigators
- Peter N Bjerring, MD, Principal investigator, Department of Hepatology, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00655304
- Sponsor's protocol ID
- ALFPROM-001
- Other IDs
- H-KF-2007-0006
- Status last verified
- Jul 2010
- First submitted
- 3 Apr 2008
- Last updated
- 27 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Prometheus (R) Liver Support Dialysis on Intracranial Pressure, Cerebral Oxidative Metabolism and Hemodynamics in Patients With Acute Liver Failure
- ClinicalTrials.gov ID
- NCT00655304
- Acronym / sponsor ID
- ALFPROM-001
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Mar 2007
- Primary completion
- Dec 2010 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 9 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: Prometheus (R) liver support dialysisTreatment with 6-8 hours of Prometheus (R) liver support dialysis |
| 2 | Active comparator | Device: CVVHDF (Continuously Veno-Venous Hemodiafiltration)Treatment with 6-8 hours of CVVHDF |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prometheus (R) liver support dialysis6-8 hours of dialysis | Device | 1 |
| CVVHDF (Continuously Veno-Venous Hemodiafiltration)6-8 hours of dialysis with the CVVHDF system PrismaFlex offered by Gambro (Sweden). | Device | 2 |
Primary outcome
treatment effect on cerebral oxidative metabolism (lactate/pyruvate-ratio)
Time frame: 24 hours
1 secondary outcome
treatment effect on intracranial pressure
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2011.
Related trials for Acute Liver Failure
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter N Bjerring, MD principal investigator
Department of Hepatology, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prometheus (R) liver support dialysis and CVVHDF (Continuously Veno-Venous Hemodiafiltration) in people with Acute Liver Failure and Hepatic Encephalopathy, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
treatment effect on cerebral oxidative metabolism (lactate/pyruvate-ratio) (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2011.