Cerebral Microdialysis in Patients With Fulminant Hepatic Failure

Fulminant Hepatic Failure Clinical Trial

Official title:

Cerebral Microdialysis in Patients With Fulminant Hepatic Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00836420
• Other study ID #: KF 00/002
• Status: Completed
• Phase: N/A
• First received: February 3, 2009
• Last updated: October 26, 2015
• Start date: January 2000
• Est. completion date: October 2015

Study information

• Verified date: October 2015
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research Ethics
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Fulminant Hepatic Failure
• Liver Failure
• Liver Failure, Acute

Intervention

Procedure:
• no intervention
the value of the clinical use of microdialysis monitoring of the brain

Locations

Country	Name	City	State
Denmark	Rigshospitalet Dept Hepatology A-2121	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

References & Publications (4)

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. — View Citation

Bjerring PN, Hauerberg J, Jørgensen 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. — View Citation

Tofteng F, Hauerberg J, Hansen BA, Pedersen CB, Jørgensen 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Brain lactate concentration and intracranial hypertension	to determine if brain oxidative metabolism correlates with brain edema and high intracranial pressure	2013	No