NCT00655304

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

April 3, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 9, 2008

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

July 27, 2011

Status Verified

July 1, 2010

Enrollment Period

3.8 years

First QC Date

April 3, 2008

Last Update Submit

July 26, 2011

Conditions

Acute Liver FailureHepatic EncephalopathyIntracranial Hypertension

Outcome Measures

Primary Outcomes (1)

  • treatment effect on cerebral oxidative metabolism (lactate/pyruvate-ratio)

    24 hours

Secondary Outcomes (1)

  • treatment effect on intracranial pressure

    24 hours

Study Arms (2)

1

ACTIVE COMPARATOR

Treatment with 6-8 hours of Prometheus (R) liver support dialysis

Device: Prometheus (R) liver support dialysis

2

ACTIVE COMPARATOR

Treatment with 6-8 hours of CVVHDF

Device: CVVHDF (Continuously Veno-Venous Hemodiafiltration)

Interventions

Prometheus (R) liver support dialysisDEVICE

6-8 hours of dialysis

1
CVVHDF (Continuously Veno-Venous Hemodiafiltration)DEVICE

6-8 hours of dialysis with the CVVHDF system PrismaFlex offered by Gambro (Sweden).

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The liverfailure unit, Department of hepatology, Rigshospitalet

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Liver Failure, AcuteHepatic EncephalopathyIntracranial Hypertension

Interventions

Continuous Renal Replacement Therapy

Condition Hierarchy (Ancestors)

Liver FailureHepatic InsufficiencyLiver DiseasesDigestive System DiseasesBrain Diseases, MetabolicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Renal Replacement TherapyTherapeuticsExtracorporeal CirculationSurgical Procedures, Operative

Study Officials

  • Peter N Bjerring, MD

    Department of Hepatology, Rigshospitalet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 3, 2008

First Posted

April 9, 2008

Study Start

March 1, 2007

Primary Completion

December 1, 2010

Study Completion

June 1, 2011

Last Updated

July 27, 2011

Record last verified: 2010-07

Locations

DK(1)