NCT00836420

Brief Summary

Patients with fulminant hepatic failure (FHF) often develop cerebral edema, high intracranial pressure (ICP)that may result in fatal brain damage. The aim in this protocol is to determine if a rise in the brain concentration of glutamate, lactate and pyruvate are involved in development of surges of high ICP in patients with FHF. The study is observatory in nature and also record the influence of any intervention that may e instituted during the course of the critical illness.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2000

Longer than P75 for all trials

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

January 1, 2000

Completed
9.1 years until next milestone

First Submitted

Initial submission to the registry

February 3, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 4, 2009

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

October 27, 2015

Status Verified

October 1, 2015

Enrollment Period

15.8 years

First QC Date

February 3, 2009

Last Update Submit

October 26, 2015

Conditions

Keywords

ammoniaacute liver failurebrain edemaoxidative metabolismintracranial pressure

Outcome Measures

Primary Outcomes (1)

  • Brain lactate concentration and intracranial hypertension

    to determine if brain oxidative metabolism correlates with brain edema and high intracranial pressure

    2013

Study Arms (1)

liver

patients with acute liver failure

Procedure: no intervention

Interventions

the value of the clinical use of microdialysis monitoring of the brain

liver

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

consecutive patients with fulminant hepatic failure

You may qualify if:

  • All patients with fulminant hepatic failure

You may not qualify if:

  • Age below 18 years
  • Pregnancy
  • Not obtained informed consent
  • Suspicion of cancer disease
  • No pupil reaction to light

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshospitalet Dept Hepatology A-2121

Copenhagen, 2100, Denmark

Location

Related Publications (4)

  • Tofteng F, Jorgensen L, Hansen BA, Ott P, Kondrup J, Larsen FS. Cerebral microdialysis in patients with fulminant hepatic failure. Hepatology. 2002 Dec;36(6):1333-40. doi: 10.1053/jhep.2002.36944.

    PMID: 12447856BACKGROUND
  • Bjerring PN, Hauerberg J, Jorgensen L, Frederiksen HJ, Tofteng F, Hansen BA, Larsen FS. Brain hypoxanthine concentration correlates to lactate/pyruvate ratio but not intracranial pressure in patients with acute liver failure. J Hepatol. 2010 Dec;53(6):1054-8. doi: 10.1016/j.jhep.2010.05.032. Epub 2010 Aug 3.

    PMID: 20800925BACKGROUND
  • Bjerring PN, Hauerberg J, Frederiksen HJ, Jorgensen L, Hansen BA, Tofteng F, Larsen FS. Cerebral glutamine concentration and lactate-pyruvate ratio in patients with acute liver failure. Neurocrit Care. 2008;9(1):3-7. doi: 10.1007/s12028-008-9060-4.

    PMID: 18250976BACKGROUND
  • Tofteng F, Hauerberg J, Hansen BA, Pedersen CB, Jorgensen L, Larsen FS. Persistent arterial hyperammonemia increases the concentration of glutamine and alanine in the brain and correlates with intracranial pressure in patients with fulminant hepatic failure. J Cereb Blood Flow Metab. 2006 Jan;26(1):21-7. doi: 10.1038/sj.jcbfm.9600168.

    PMID: 15959460BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

microdialysate from the brain as part of rutine monitoring

MeSH Terms

Conditions

Liver Failure, AcuteBrain Edema

Condition Hierarchy (Ancestors)

Liver FailureHepatic InsufficiencyLiver DiseasesDigestive System DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Fin Stolze Larsen

    Rigshospitalet, Denmark

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
consultant

Study Record Dates

First Submitted

February 3, 2009

First Posted

February 4, 2009

Study Start

January 1, 2000

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

October 27, 2015

Record last verified: 2015-10

Locations