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Cerebral Microdialysis in Patients With Fulminant Hepatic Failure

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00836420
First Posted: February 4, 2009
Last Update Posted: October 27, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Dr. Fin Stolze Larsen, Rigshospitalet, Denmark
  Purpose
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.

Condition Intervention
Fulminant Hepatic Failure Procedure: no intervention

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Cerebral Microdialysis in Patients With Fulminant Hepatic Failure

Further study details as provided by Dr. Fin Stolze Larsen, Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Brain lactate concentration and intracranial hypertension [ Time Frame: 2013 ]
    to determine if brain oxidative metabolism correlates with brain edema and high intracranial pressure


Biospecimen Retention:   Samples Without DNA
microdialysate from the brain as part of rutine monitoring

Enrollment: 50
Study Start Date: January 2000
Study Completion Date: October 2015
Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
liver
patients with acute liver failure
Procedure: no intervention
the value of the clinical use of microdialysis monitoring of the brain

Detailed Description:
Fulminant hepatic failure (FHF) is often complicated by cerebral edema, high intracranial pressure (ICP) and brain death. Accordingly the intracranial pressure is often monitored in such patients in order to be able to institute treatment before high ICP evolves. As routinely done in patients with severe head injury a microdialysis monitoring catheter is also placed under this procedure to measure metabolic changes that are responsible for surges of high ICP. The aim in this descriptive protocol is to determine if a rise in glutamate, lactate and pyruvate concentration in the brain cortex 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 during the course of the critical illness.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
consecutive patients with fulminant hepatic failure
Criteria

Inclusion Criteria:

  • All patients with fulminant hepatic failure

Exclusion Criteria:

  • Age below 18 years
  • Pregnancy
  • Not obtained informed consent
  • Suspicion of cancer disease
  • No pupil reaction to light
  Contacts and Locations
Information from the National Library of Medicine

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): NCT00836420


Locations
Denmark
Rigshospitalet Dept Hepatology A-2121
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
Study Chair: Fin Stolze Larsen Rigshospitalet, Denmark
  More Information

Publications:
Responsible Party: Dr. Fin Stolze Larsen, consultant, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT00836420     History of Changes
Other Study ID Numbers: KF 00/002
First Submitted: February 3, 2009
First Posted: February 4, 2009
Last Update Posted: October 27, 2015
Last Verified: October 2015

Keywords provided by Dr. Fin Stolze Larsen, Rigshospitalet, Denmark:
ammonia
acute liver failure
brain edema
oxidative metabolism
intracranial pressure

Additional relevant MeSH terms:
Liver Failure
Liver Failure, Acute
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases


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