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Cerebral Microdialysis in Patients With Fulminant Hepatic Failure

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Rigshospitalet, Denmark
Sponsor:
Information provided by (Responsible Party):
Dr. Fin Stolze Larsen, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT00836420
First received: February 3, 2009
Last updated: November 4, 2014
Last verified: November 2014
  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

Resource links provided by NLM:


Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Brain lactate concentration and intracranial hypertension [ Time Frame: 2013 ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 100
Study Start Date: January 2000
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: January 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00836420

Contacts
Contact: Fin Stolze Larsen, MD, PhD, DSc +4535452155 stolze@post3.tele.dk
Contact: Bent Adel Hansen, MD, DSc +4535452357 rh01988@rh.dk

Locations
Denmark
Rigshospitalet Dept Hepatology A-2121 Recruiting
Copenhagen, Denmark, 2100
Contact: Fin Stolze Larsen    +4535452357    rh15010@rh.dk   
Principal Investigator: Fin Stolze Larsen         
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
Study First Received: February 3, 2009
Last Updated: November 4, 2014
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by Rigshospitalet, Denmark:
ammonia
acute liver failure
brain edema
oxidative metabolism
intracranial pressure

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

ClinicalTrials.gov processed this record on November 27, 2014