Neuromonitoring of Hepatic Encephalopathy

Hepatic Encephalopathy Clinical Trial

Official title:

Frontal Electroencephalogram Variables Are Associated With Outcome and Stage of Hepatic Encephalopathy in Acute Liver Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01878305
• Other study ID #: HUS2344
• Secondary ID: 1104/10
• Status: Completed
• Phase: N/A
• First received: June 6, 2013
• Last updated: June 12, 2013
• Start date: December 2005
• Est. completion date: December 2011

Study information

• Verified date: June 2013
• Source: Helsinki University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ethics Committee
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• age 18 or over

• acute liver failure, referred to the ICU of the Surgical Hospital

Exclusion Criteria:

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Brain Diseases
• Hepatic Encephalopathy
• Liver Failure
• Liver Failure, Acute

Intervention

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.

Locations

Country	Name	City	State
Finland	Helsinki University Central Hospital, Department of Anesthesiology and Intensive Care	Helsinki	Uudenmaan lääni

Sponsors (2)

Lead Sponsor	Collaborator
Helsinki University	GE Healthcare

Country where clinical trial is conducted

Finland, 

References & Publications (4)

Frenzel D, Greim CA, Sommer C, Bauerle K, Roewer N. Is the bispectral index appropriate for monitoring the sedation level of mechanically ventilated surgical ICU patients? Intensive Care Med. 2002 Feb;28(2):178-83. Epub 2002 Jan 12. — View Citation

Tiainen M, Roine RO, Pettilä V, Takkunen O. Serum neuron-specific enolase and S-100B protein in cardiac arrest patients treated with hypothermia. Stroke. 2003 Dec;34(12):2881-6. Epub 2003 Nov 20. — View Citation

Vakkuri A, Yli-Hankala A, Talja P, Mustola S, Tolvanen-Laakso H, Sampson T, Viertiö-Oja H. Time-frequency balanced spectral entropy as a measure of anesthetic drug effect in central nervous system during sevoflurane, propofol, and thiopental anesthesia. Acta Anaesthesiol Scand. 2004 Feb;48(2):145-53. — View Citation

Wennervirta J, Salmi T, Hynynen M, Yli-Hankala A, Koivusalo AM, Van Gils M, Pöyhiä R, Vakkuri A. Entropy is more resistant to artifacts than bispectral index in brain-dead organ donors. Intensive Care Med. 2007 Jan;33(1):133-6. Epub 2006 Nov 8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants recovering without the need for a liver transplant		Participant will be followed for the duration of their intensive care stay, an expected average of two weeks	No