An observational study in Liver Failure, Acute and Hepatic Encephalopathy, sponsored by University of Helsinki. Completed at 1 site in Finland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-06-14.
Sponsored by University of Helsinki · Observational
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.
445 studies on the registry are indexed under Liver Failure; 69 are open to participants now.
This study's enrollment of 20 is below the median of 129 across 146 observational studies indexed under Liver Failure.
Browse Liver Failure studies →University of Helsinki is the lead sponsor of 129 studies on the registry; 19 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All acute liver failure patients meeting the inclusion criteria, referred to the intensive care unit of the Surgical Hospital of Helsinki, Finland, for evaluation for the need of a liver transplant. The total study size was set to twenty patients, and recruitment was continued until the set number was met.
Exclusion Criteria:
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Study patients are treated with albumin dialysis (Molecular Adsorbents recirculating system), based on the clinical judgement by the treating physician. Of the 20 patients, two did not need MARS and the rest received MARS treatment with varying treatment cycles.
Device: Molecular Adsorbent Recirculating System (MARS)
MARS is an extracorporeal albumin dialysis device, used in the treatment of liver failure patients to stabilize the patient and halt the progression of HE, giving the liver time to recover in some cases and allowing additional time before liver transplantation in others.
Number of participants recovering without the need for a liver transplant
Time frame: Participant will be followed for the duration of their intensive care stay, an expected average of two weeks
This study is completed, as verified in Jun 2013. You cannot join it, but the record below documents what was studied.
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University of Helsinki