Hepatic Encephalopathy Clinical Trial
Official title:
Frontal Electroencephalogram Variables Are Associated With Outcome and Stage of Hepatic Encephalopathy in Acute Liver Failure
Neuromonitoring of critically ill patients in the intensive care unit (ICU) is challenging.
Clinical scoring systems produce insufficient information with deeply sedated patients, and
disturbances of normal hemostasis limit the use of invasive intra-cranial pressure
measurements. EEG based monitoring algorithms have been introduced into the operation
theater and general anaesthesia, but these algorithms cannot be used in the intensive care
setting without modifications. EEG is also susceptible to electrical disturbances, such as
those created by patient movement.
The study is conducted in Finland, in the intensive care unit of the Surgical Hospital of
Helsinki. The total number of patients in this study is 20, and it is a part of a larger
neuromonitoring study with a total of 110 patients. The patients are divided into four
subgroups, as follows: 1. patients admitted to ICU with acute liver failure, 2. patients
admitted to the postoperative cardio-thoracic ICU after cardiac surgery with perioperative
total heart arrest, 3. patients admitted to the ICU because of status epilepticus and
finally 4. patients in critical condition, admitted to the ICU after any surgery. This study
concentrates on the first group of patients with acute liver failure.
Clinical care of patients is not altered. When arriving into the ICU EEG-monitoring will
added to routine monitoring. To evaluate the neurological status the following tests are
performed: clinical test, blood tests and transcranial doppler ultrasound. The Entropy of
EEG is measured along with the raw EEG signal.
The recruiting of study patients was begun in December 2005 and the final study patients
were recruited in December 2011. GE Healthcare Finland supplies the entropy monitoring
devices and pays the salary of the research nurses who collect the study data. Clinical
investigators will not receive funding from any commercial company. All patients (or their
next of kin) included have given their written informed consent for inclusion in the study.
The aim of this study is to find new factors and new non-invasive techniques, which
correlate with the neurological state and outcome of patients suffering critical illness.
n/a
Observational Model: Case-Only, Time Perspective: Prospective
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