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Completed

NCT Number: NCT00836420

Cerebral Microdialysis in Patients With Fulminant Hepatic Failure

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.

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Key information

Conditions

Fulminant Hepatic Failure Brain Diseases Brain Edema Central Nervous System Diseases Digestive System Diseases Hepatic Insufficiency Liver Diseases Liver Failure Liver Failure, Acute Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Rigshospitalet Dept Hepatology A-2121

Copenhagen, 2100, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Procedure

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

Primary outcomes

  1. Brain lactate concentration and intracranial hypertension

    Time frame: 2013

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

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Important dates

Study start
2000
Primary completion
2015
Study completion
2015
First posted
Feb 4, 2009
Registry last updated
Oct 27, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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