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Neuromonitoring of Hepatic Encephalopathy

NCT01878305 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2013-06-14

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • GE Healthcare

    collaborator INDUSTRY

  • University of Helsinki

    lead OTHER

Principal Investigators

  • Anne P Vakkuri, MD, PhD · Helsinki University Central Hospital, Department of Anesthesiology and Intensive Care

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-12-31
Primary Completion
2011-12-31
Completion
2011-12-31

Countries

  • Finland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01878305 on ClinicalTrials.gov