Neuromonitoring of Hepatic Encephalopathy

NCT01878305 | Completed

• 2 other identifiers: HUS23441104/10
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Liver Failure, Acute; Hepatic Encephalopathy

Keywords

hepatic encephalopathy; brain waves; electroencephalogram; transcranial Doppler ultrasonography; physiological monitoring; intensive care

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

MARS

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)

Interventions

Molecular Adsorbent Recirculating System (MARS) DEVICE

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.

MARS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• age 18 or over
• acute liver failure, referred to the ICU of the Surgical Hospital

Sponsors & Collaborators

• University of Helsinki: lead
• GE Healthcare: collaborator

Study Sites (1)

Helsinki University Central Hospital, Department of Anesthesiology and Intensive Care

Helsinki, Uudenmaan Lääni, 00029, Finland

Location

Related 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. doi: 10.1007/s00134-001-1183-4. Epub 2002 Jan 12.

  PMID: 11907661 BACKGROUND

• Wennervirta J, Salmi T, Hynynen M, Yli-Hankala A, Koivusalo AM, Van Gils M, Poyhia 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. doi: 10.1007/s00134-006-0429-6. Epub 2006 Nov 8.

  PMID: 17091243 BACKGROUND

• Tiainen M, Roine RO, Pettila 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. doi: 10.1161/01.STR.0000103320.90706.35. Epub 2003 Nov 20.

  PMID: 14631087 BACKGROUND

• Vakkuri A, Yli-Hankala A, Talja P, Mustola S, Tolvanen-Laakso H, Sampson T, Viertio-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. doi: 10.1111/j.0001-5172.2004.00323.x.

  PMID: 14995935 BACKGROUND

MeSH Terms

Conditions

Liver Failure, Acute; Hepatic Encephalopathy

Condition Hierarchy (Ancestors)

Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases; Brain Diseases, Metabolic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Anne P Vakkuri, MD, PhD

  Helsinki University Central Hospital, Department of Anesthesiology and Intensive Care

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Juhani Akseli Stewart, MD

Study Record Dates

• First Submitted: June 6, 2013
• First Posted: June 14, 2013
• Study Start: December 1, 2005
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: June 14, 2013

Record last verified: 2013-06

Locations

FI (1)